DATA-CYTE PLUS P 0.8%
Report
- Report Number
- 3002806769-2025-00007
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- July 11, 2025
- Report Date
- August 11, 2025
- Manufacturer
- MEDION GRIFOLS DIAGNOSTICS AG,
- Product Code
- QHT
- UDI-DI
- 07640137342272
- PMA / PMN Number
- BL103898
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
I. DOCUMENTARY INVESTIGATION: THE MANUFACTURING DOCUMENTATION OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, WAS REVIEWED AND NO DEVIATIONS WERE FOUND THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. ALL INTERNAL TESTS PERFORMED DURING THE MANUFACTURING PROCESS WERE WITHIN INTERNAL SPECIFICATIONS. NOTABLY, AT RELEASE TESTING, ANTIGEN TYPING WAS PERFORMED WITH ANTI-K REAGENT ON DG GEL 8 NEUTRAL CARD AND ALL RRBCS POSITIVE FOR THIS ANTIGEN (CELL 2 (K+K+), CELL 8 (K+K-) AND CELL 11 (K+K+)) REACTED POSITIVE. CELL 1P (K-, JKA+B-), CELL 2P (K+K+, JKA-), CELL 5P (K-, JKA+B+), CELL 6P (K-, JKA+B-), CELL 8P (K+K-, JKA+B+), CELL 9P (K-, JKA+B-) AND CELL 11P (K+K+, JKA+B+) OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF THESE DONORS WAS REVIEWED, AND NO DEVIATIONS WERE FOUND. ALL DONORS WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT ANTISERA OF EACH SPECIFICITY (ANTI-K, ANTI-JKA). FOR THE ANTIGENS K AND JKA, ALL THESE DONORS REACTED AS INDICATED IN THE ANTIGEN MATRIX OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. THE HISTORY OF DONORS (B)(6) WAS REVIEWED. DONORS (B)(6) ARE NEW DONORS; THEIR FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF SIX FINISHED PRODUCTS IN THE SAME MANUFACTURING CAMPAIGN, INCLUDING AS CELL 1P, CELL 2P, CELL 6P AND CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, RESPECTIVELY. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG TO DATE INVOLVING THESE DONORS, EXCEPT FOR DONOR (B)(6) INVOLVED IN ONE COMPLAINT THAT IS CURRENTLY ONGOING BUT INVOLVES ANOTHER SPECIFICITY AND ANOTHER (NON-PAPAINIZED) CLAIMED PRODUCT. SIX BLOOD UNITS FROM DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF TWENTY-ONE FINISHED PRODUCTS IN SIX DIFFERENT MANUFACTURING CAMPAIGNS, INCLUDING AS CELL 5P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. BESIDES THE CURRENT REPORTED EVENT, THERE HAVE BEEN TWO OTHER COMPLAINTS REGISTERED FOR A PRODUCT MANUFACTURED AND INVOLVING DONOR (B)(6). NEVERTHELESS, THESE TWO COMPLAINTS INVOLVED SEVERAL CELLS FROM THE SAME CLAIMED (NON-PAPAINIZED) PRODUCT AND THE COMPLAINTS WERE NON-CONFIRMED AFTER INVESTIGATION. TWO BLOOD UNITS FROM DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF ELEVEN FINISHED PRODUCTS IN TWO DIFFERENT MANUFACTURING CAMPAIGNS, INCLUDING AS CELL 9P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG TO DATE INVOLVING THIS DONOR. TWO BLOOD UNITS FROM DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF SEVEN FINISHED PRODUCTS IN TWO DIFFERENT MANUFACTURING CAMPAIGNS, INCLUDING AS CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG TO DATE INVOLVING THIS DONOR. INTERNAL STABILITY RECORDS OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, WERE REVIEWED. THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. II. INVESTIGATIVE TESTING: ON 24 JULY 2025, INVESTIGATIVE TESTING USING POLYCLONAL ANTI-K AND ANTI-JKA FROM HUMAN PLASMA WITH SELECTED RRBCS FROM DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02 (PAPAINIZED PANEL), AND DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02 (NATIVE PANEL), INCLUDING THE RRBCS BEING POSITIVE FOR THE TESTED ANTIBODY SPECIFICITY AS WELL AS ONE NEGATIVE CONTROL RRBC, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE SELECTED RRBCS WERE TESTED EACH IN DG GEL 8 ANTI-IGG CARD, LOT: 24033.01, EXP. 2025-07-31, AND IN DG GEL 8 NEUTRAL CARD, LOT: 24017.01, EXP. 2025-07-31; EACH PANEL WAS TESTED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) (NATIVE (NON-PAPAINIZED) PANEL IN ANTI-IGG CARDS; PAPAINIZED PANEL IN NEUTRAL CARDS) AS WELL AS WITH THE OTHER CARD FOR INVESTIGATION (NATIVE (NON-PAPAINIZED) PANEL IN NEUTRAL CARDS; PAPAINIZED PANEL IN ANTI-IGG CARDS). EACH TEST WAS PERFORMED BY PIPETTING 50 L 0.8% RRBCS AND 25 L POLYCLONAL ANTIBODY FROM HUMAN PLASMA, FOLLOWED BY 15 MINUTES INCUBATION AT 37°C AND 9 MINUTES CENTRIFUGATION. FOR ANTI-K: THE NATIVE K+ CELL 2 (K+K+), CELL 8 (K+K-) AND CELL 11 (K+K+) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02, WERE ALL INTERPRETED AS 3+, INDEPENDENTLY FROM THE ZYGOSITY OF THE CELLS WHEN TESTED IN DG GEL 8 ANTI-IGG CARD, AS PER IFU TECHNIQUE. THE CLAIMED PAPAINIZED K+ CELL 2P (K+K+), CELL 8P (K+K-) AND CELL 11P (K+K+) OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, WERE ALL INTERPRETED AS POSITIVE (2+ TO 3+) AS EXPECTED WHEN TESTED IN DG GEL 8 NEUTRAL CARD, AS PER IFU TECHNIQUE, DEMONSTRATING THE RESISTANCE IN ENZYMATIC METHOD AS PER LITERATURE. REGARDING THE TWO INVESTIGATIVE TESTS, WHEN THE PAPAINIZED PANEL CELLS WERE TESTED IN DG GEL 8 ANTI-IGG CARD, THE REACTIVITY WAS 3+ TO 4+/3+ FOR THE K+ CELLS IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 NEUTRAL CARD (2+ TO 3+). ON THE OTHER HAND, WHEN NATIVE PANEL CELLS WERE TESTED IN DG GEL 8 NEUTRAL CARD, THE K+ CELLS WERE INTERPRETED AS NEGATIVE (HETEROZYGOUS CELL 2), +/- (HETEROZYGOUS CELL 11) AND 1+ (HOMOZYGOUS CELL 8) IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 ANTI-IGG CARD, WHERE 3+ REACTIONS WERE OBSERVED FOR ALL NATIVE K+ CELLS (HETEROZYGOUS AND HOMOZYGOUS). THIS INVESTIGATIVE TESTING DEMONSTRATES THE INFLUENCE/IMPORTANCE OF ANTI-IGG IN THE REACTIVITY. AS MENTIONED IN THE LITERATURE, ANTI-K, LIKE OTHER KELL SYSTEM ANTIBODIES, ARE GENERALLY IGG TYPE, AND PREDOMINANTLY IGG1. ALTHOUGH IGG ANTI-K MAY OCCASIONALLY AGGLUTINATE K+ RED CELLS DIRECTLY, THE ANTIGLOBULIN TEST IS USUALLY THE METHOD OF CHOICE. HOWEVER, OCCASIONALLY, ANTI-K ANTIBODIES OF IGM TYPE MAY ALSO BE PRESENT. THE NEGATIVE CONTROL CELL 1/1P REACTED NEGATIVE AS EXPECTED IN ALL TESTING. NEVERTHELESS, WITH THE POLYCLONAL ANTI-K FROM HUMAN PLASMA USED IN THE TESTING, THE REPORTED UNEXPECTED NEGATIVE AND DOUBTFUL REACTIONS WITH CELL 2P, CELL 8P AND CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, HAVE NOT BEEN REPRODUCED IN MEDION GRIFOLS DIAGNOSTICS AG. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL K ANTIGEN EXPRESSION OF THE CLAIMED CELL 2P, CELL 8P AND CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. FOR ANTI-JKA: THE NATIVE JKA+ CELL 1 (JKA+B-), CELL 5 (JKA+B+), CELL 6 (JKA+B-), CELL 8 (JKA+B+), CELL 9 (JKA+B-) AND CELL 11 (JKA+B+) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02, WERE INTERPRETED AS NEGATIVE (CELL 5), 1+ (CELL 8) AND +/- (CELL 11) FOR THE HETEROZYGOUS CELLS AND AS 2+ FOR THE HOMOZYGOUS CELL 1, CELL 6 AND CELL 9 WHEN TESTED IN DG GEL 8 ANTI-IGG CARD, AS PER IFU TECHNIQUE. THE CLAIMED PAPAINIZED JKA+ CELLS OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, WERE INTERPRETED AS POSITIVE (1+) AS EXPECTED FOR THE HOMOZYGOUS CELL 1P, CELL 6P AND CELL 9P, WHILE TWO (CELL 5P AND CELL 11P) OUT OF THE THREE HETEROZYGOUS CELLS WERE INTERPRETED AS NEGATIVE (CELL 8P WAS INTERPRETED +/-) WHEN TESTED IN DG GEL 8 NEUTRAL CARD, AS PER IFU TECHNIQUE. WHILE SOME JKA+ (HETEROZYGOUS) CELLS DID NOT SHOW REACTIVITY DURING THE INVESTIGATIVE TESTING, 4 OUT OF THE 6 JKA+ CELLS REACTED, UNLIKE AS OBSERVED BY THE CUSTOMER (ONLY CELL 1P REACTED OUT OF THE SIX CELLS). NEVERTHELESS, THE REACTIVITY WAS NOT ENHANCED WITH THE PAPAINIZED CELLS WHEN TESTED IN NEUTRAL CARDS IN COMPARISON TO THE NATIVE CELLS TESTED IN ANTI-IGG CARDS, SIMILARLY TO WHAT WAS OBSERVED BY THE CUSTOMER. REGARDING THE TWO INVESTIGATIVE TESTS, WHEN THE PAPAINIZED PANEL CELLS WERE TESTED IN DG GEL 8 ANTI-IGG CARD, THE REACTIVITY WAS 3+ FOR ALL THREE HOMOZYGOUS CELLS, AND BETWEEN 2+ AND 3+ FOR THE THREE HETEROZYGOUS JKA+ CELLS, SHOWING A CLEAR ENHANCEMENT IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 NEUTRAL CARD (NEG TO 1+). ON THE OTHER HAND, WHEN NATIVE PANEL CELLS WERE TESTED IN DG GEL 8 NEUTRAL CARD, ALL JKA+ CELLS WERE INTERPRETED AS NEGATIVE, IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 ANTI-IGG CARD, WHERE NEGATIVE TO 1+ REACTIONS FOR THE HETEROZYGOUS CELLS AND 2+ REACTIONS FOR THE HOMOZYGOUS NATIVE CELLS WERE OBTAINED. THE NEGATIVE CONTROL CELL 2/2P REACTED NEGATIVE AS EXPECTED IN ALL TESTING. WITH THE POLYCLONAL ANTI-JKA FROM HUMAN PLASMA USED IN THE TESTING, THE REPORTED UNEXPECTED WEAKER/NEGATIVE REACTIONS WITH CELL 1P, CELL 5P, CELL 6P, CELL 8P, CELL 9P AND CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, COULD HAVE PARTIALLY BEEN REPRODUCED IN MEDION GRIFOLS DIAGNOSTICS AG. NEVERTHELESS, THE INVESTIGATIVE TESTING DEMONSTRATED THE INFLUENCE/IMPORTANCE OF ANTI-IGG IN THE REACTIVITY AND DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL JKA ANTIGEN EXPRESSION OF THE CLAIMED CELL 1P, CELL 5P, CELL 6P, CELL 8P, CELL 9P AND CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. BASED ON THE ELEMENTS ABOVE, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENTS IS SAMPLE RELATED, POINTING TO THE INHERENT FEATURES OF THE ANTIBODIES WITH K AND JKA SPECIFICITY PRESENT IN THE PLASMA OF THE TWO DIFFERENT PATIENTS. REGARDING THE ANTI-K IN SAMPLE "(B)(6)", THE ANTIBODY WAS DETECTED BY BOTH NATIVE AND PAPAINIZED PANELS WHEN TESTED WITH A POLYCLONAL ANTI-K FROM HUMAN SOURCE AT MEDION GRIFOLS DIAGNOSTICS AG. THE CUSTOMER WAS REPORTING WEAK/NEGATIVE REACTIVITY FOR ALL K+ PAPAINIZED PANEL CELLS (CELL 2P, CELL 8P AND CELL 11P) WHEN TESTED IN DG GEL 8 NEUTRAL CARDS. NEVERTHELESS, WITH THE POLYCLONAL ANTI-K FROM HUMAN PLASMA USED IN THE TESTING AT MEDION GRIFOLS DIAGNOSTICS AG, THE REPORTED UNEXPECTED WEAK/NEGATIVE REACTIONS WITH CELL 2P, CELL 8P AND CELL 11P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, HAVE NOT BEEN REPRODUCED. EVEN THOUGH THE PAPAINIZED CELLS GAVE SLIGHT WEAKER REACTIVITY, THESE CELLS GAVE REACTIONS GRADED BETWEEN 2+ AND 3+. ALSO, THE INVESTIGATIVE TESTING DEMONSTRATED THE INFLUENCE/IMPORTANCE OF ANTI-IGG IN THE REACTIVITY (NATIVE CELLS WEAK/NEGATIVE IN NEUTRAL, PAPAINIZED CELLS FURTHER ENHANCED IN ANTI-IGG). REGARDING THE ANTI-JKA IN SAMPLE "(B)(6)", THE ANTIBODY WAS DETECTED BY THE NATIVE CELLS IN ANTI-IGG CARD WHEN TESTED AT CUSTOMER SITE, AND PARTIALLY DURING THE INVESTIGATION AT MEDION GRIFOLS DIAGNOSTICS AG WITH THE NATIVE CELLS IN ANTI-IGG CARD (ONE CELL REACTED NEGATIVE). HOWEVER, WHILE THE CUSTOMER DID MOSTLY NOT DETECT THE ANTIBODY WITH THE PAPAINIZED CELLS IN NEUTRAL CARDS, THE THREE HOMOZYGOUS AND ONE OF THE THREE HETEROZYGOUS PAPAINIZED CELLS DETECTED THE POLYCLONAL ANTI-JKA FROM HUMAN SOURCE DURING THE INVESTIGATIVE TESTING WHEN TESTED IN NEUTRAL CARD, AND THE ANTIBODY WAS SIGNIFICANTLY ENHANCED IN THE PAPAINIZED CELLS IN THE ANTI-IGG CARD (2+ TO 3+ REACTIONS), AS ALSO OBSERVED BY THE CUSTOMER. THEREFORE, THE INVESTIGATIVE TESTING DEMONSTRATED THE INFLUENCE/IMPORTANCE OF ANTI-IGG IN THE REACTIVITY (ALL NATIVE CELLS NEGATIVE IN NEUTRAL, PAPAINIZED CELLS SIGNIFICANTLY ENHANCED IN ANTI-IGG). IT SHALL BE NOTED THAT THE PRODUCT DATA-CYTE PLUS P 0.8%, REF. 213688, IS NOT USED ALONE BUT IN CONJUNCTION WITH DATA-CYTE PLUS 0.8%, REF. 213654. NO WRONG INTERPRETATION WAS MADE, AS THE ANTIBODIES WERE READILY DETECTED WITH THE UNTREATED (NATIVE) PANEL AND IS THEREFORE RELATED TO THE ANTIBODIES' NATURE WHICH MAY BE DEPENDENT ON THE PRESENCE OF ANTI-IGG IN THE TEST METHOD AS STATED ABOVE. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.
A CUSTOMER REPORTED UNEXPECTED WEAKER AND/OR NEGATIVE REACTIONS ON TWO ERYTRA INSTRUMENTS FOR TWO PATIENTS, OBTAINED WITH CELL 1P (K-, JKA+B-; DONOR (B)(6), CELL 2P (K+K+, JKA-; DONOR (B)(6), CELL 5P (K-, JKA+B+; DONOR (B)(6), CELL 6P (K-, JKA+B-; DONOR (B)(6), CELL 8P (K+K-, JKA+B+; DONOR (B)(6), CELL 9P (K-, JKA+B-; DONOR (B)(6) AND CELL 11P (K+K+, JKA+B+; DONOR (B)(6) OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02 (UDI: (B)(4). THIS OCCURRED WITH TWO PATIENT SAMPLES (SAMPLE "(B)(6)" WITH AN ANTI-K AND SAMPLE "(B)(6)" WITH AN ANTI-JKA) DURING VALIDATION OF DATA-CYTE PLUS P 0.8% (REF. 213688) BY COMPARATIVE TESTING WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02. WHILE THE UNTREATED (NATIVE) PANEL CELLS SUCCESSFULLY DEMONSTRATED THE PRESENCE OF EACH ANTI-K AND ANTI-JKA IN THE RESPECTIVE PATIENT SAMPLES IN DG GEL 8 ANTI-IGG CARDS, SOME ENZYME TREATED (PAPAINIZED) PANEL CELLS SHOWED WEAKER AND/OR DID NOT REACT IN DG GEL 8 NEUTRAL CARDS. ACCORDING TO THE INFORMATION PROVIDED: SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 74-YEAR-OLD FEMALE PATIENT WITH AN ANTI-JKA ADMITTED TO ER FOR A FALL (NO OTHER DIAGNOSIS), WITH NO INFORMATION ABOUT MEDICATIONS. REGARDING TRANSFUSION HISTORY, THE PATIENT HAS NEVER BEEN TRANSFUSED AT CUSTOMER FACILITY, WITH NO FURTHER INFORMATION. THE SAMPLE WAS TESTED ON (B)(6) 2025 AT 09H19 FOR ANTIBODY IDENTIFICATION ON EFL1256 WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, LOT: 25006.1, EXP. 2026-01-31. ALL PAPAINIZED PANEL CELLS WERE INTERPRETED AS NEGATIVE BY THE INSTRUMENT, EXCEPT HOMOZYGOUS CELL 1P (JKA+B-) AND CELL 9P (JKA+B-) WHICH WERE INTERPRETED AS 1+ AND DOUBTFUL "?" (MODIFIED TO W+ BY OPERATOR), RESPECTIVELY. THE THREE HETEROZYGOUS JKA+B+ CELL 5P, CELL 8P AND CELL 11P WERE INTERPRETED AS NEGATIVE BY THE INSTRUMENT, AND THE THIRD HOMOZYGOUS JKA+B- CELL 6P WAS ALSO INTERPRETED AS NEGATIVE, HOWEVER A ROUNDED PELLET WITH VERY FEW AGGLUTINATES ABOVE THE PELLET COULD BE OBSERVED. THE SAMPLE WAS PROCESSED LATER AT 10H57 ON THE SAME INSTRUMENT FOR ANTIBODY IDENTIFICATION WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02, ON DG GEL 8 ANTI-IGG CARD, LOT: 24041.1, EXP. 2025-09-30, AND ALL JKA+ CELLS REACTED POSITIVE. THE THREE HOMOZYGOUS CELL 1, CELL 6 AND CELL 9 WERE INTERPRETED AS 2+, WHILE TWO HETEROZYGOUS CELLS (CELL 5 AND CELL 11) WERE INTERPRETED AS 1+. THE THIRD HETEROZYGOUS CELL 8 WAS INTERPRETED AS 2+ BY THE INSTRUMENT, SIMILARLY TO THE HOMOZYGOUS CELLS. ALL THE OTHER CELLS REACTED NEGATIVE, INCLUDING THE AUTOCONTROL. ANOTHER SAMPLE "(B)(6)" ORIGINATING FROM THE SAME PATIENT (UNKNOWN COLLECTION DATE) WAS TESTED ON 15 JULY 2025 AT 12H59 ON THE SAME INSTRUMENT WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, LOT: 25006.1, EXP. 2026-01-31. THE HOMOZYGOUS CELL 1P WAS AGAIN INTERPRETED AS 1+, AND THE TWO OTHER HOMOZYGOUS CELL 6P AND CELL 9P WERE INTERPRETED AS NEGATIVE, HOWEVER A ROUNDED PELLET COULD BE OBSERVED FOR BOTH CELLS. THE THREE HETEROZYGOUS CELL 5P, CELL 8P AND CELL 11P WERE INTERPRETED AS NEGATIVE BY THE INSTRUMENT. SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM AN 84-YEAR-OLD MALE PATIENT WITH AN ANTI-K DIAGNOSED WITH ARRHYTHMIA AND SICK SINUS SYNDROME, NO INFORMATION ABOUT MEDICATIONS. REGARDING TRANSFUSION HISTORY, THE PATIENT HAS NEVER BEEN TRANSFUSED AT CUSTOMER FACILITY AND HAS ANSWERED NO TO PREVIOUS TRANSFUSIONS. THE SAMPLE WAS TESTED ON (B)(6) 2025 AT 10H48 FOR ANTIBODY IDENTIFICATION ON EFL1256 WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT: 610025013, EXP. 2025-08-02, ON DG GEL 8 ANTI-IGG CARD, LOT: 24041.1, EXP. 2025-09-30. BOTH HETEROZYGOUS CELL 2 (K+K+) AND CELL 11 (K+K+) WERE INTERPRETED AS 2+ AND THE HOMOZYGOUS CELL 10 (K+K-) WAS INTERPRETED AS 3+ BY THE INSTRUMENT, WHILE ALL THE OTHER CELLS REACTED NEGATIVE, INCLUDING THE AUTOCONTROL. THE SAMPLE WAS PROCESSED ON (B)(6) 2025 AT 11H14 ON THE SAME INSTRUMENT FOR ANTIBODY IDENTIFICATION WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, ON DG GEL 8 NEUTRAL CARD, LOT: 25006.1, EXP. 2026-01-31, AND BOTH HETEROZYGOUS CELL 2P AND CELL 11P REACTED NEGATIVE WHILE THE HOMOZYGOUS CELL 10P WAS INTERPRETED AS DOUBTFUL "?" BY THE INSTRUMENT. ALL THE OTHER PAPAINIZED PANEL CELLS REACTED NEGATIVE. NO ALTERNATIVE TESTING WAS PERFORMED. AS PER L2 INVESTIGATION, INVESTIGATION OF THE RAW IMAGES SHOWED THAT NEUTRAL CARD (B)(6) USED FOR THE FIRST TESTING OF SAMPLE (B)(6) WITH PAPAINIZED PANEL SHOWED SLIGHT MOUNDING ON CELL 6P (JKA+B-) IN POST PROCESSING IMAGES. FOR THE SAME SAMPLE, IN THE INTEGRITY CHECK IMAGES THE IGG CARD USED FOR THE TESTING WITH NATIVE PANEL SHOWED DRIED BUFFER SPLASHING ON WELLS 7 AND 8 OF CARD (B)(6) AND SLIGHT BUFFER SPLASHING ON CARD (B)(6) IN WELL 2. LOG REVIEW SHOWED NO ERRORS DURING THE TIME OF TESTING. FOR THE OTHER SAMPLE, THE REVIEW OF THE RAW IMAGES SHOWED NO SIGNS OF BUFFER SPLASHING OR GEL DISPLACEMENT, AND POST PROCESSING IMAGES SHOWED REACTIONS THAT AGREED WITH THE INSTRUMENT GRADING ALGORITHM. INSTRUMENT LOGS WERE REVIEWED AND SHOWED NO ERRORS DURING THE PROCESSING OF THE SAMPLE. REVIEW OF THE INVESTIGATION HAS ONE SAMPLE SUBMITTED THAT HAD ANTIBODIES THAT ARE ENHANCED BY PAPAIN TREATMENT (ANTI-JKA). THE ANTI-JKA SAMPLE MAY BE COMPLEMENT BINDING BUT DOES NOT ACCOUNT FOR THE DIFFERENCE IN REACTIVITY FROM THE NATIVE PANEL IN IGG CARDS. FINALLY, THE DECREASE REACTION FROM THE ANTI-K SAMPLE WHICH SHOULD HAVE EXHIBITED NO CHANGE IN REACTIVITY BUT SCORES OF 3+ AND 2+ WERE UNEXPECTEDLY EITHER NEGATIVE OR? ON TESTING USING THE PAPAINIZED PANEL. UPON REQUEST, THE CUSTOMER PERFORMED INVESTIGATIVE TESTING WITH THE SAMPLES FROM THE TWO PATIENTS USING CLAIMED PRODUCT DATA-CYTE PLUS P 0.8%, REF. 213688, LOT: 614025013, EXP. 2025-08-02, IN DG GEL 8 ANTI-IGG CARDS INSTEAD OF DG GEL 8 NEUTRAL CARDS, WITH THE USUAL 15 MIN INCUBATION AT 37°C: SAMPLE "(B)(6)" (ANTI-K): WHEN TESTED AT CUSTOMER IN DG GEL 8 ANTI-IGG CARDS, ALL PAPAINIZED PANEL K+ CELLS REACTED BETWEEN 2+ (HETEROZYGOUS CELL 11P) AND 3+ (HETEROZYGOUS CELL 2P AND HOMOZYGOUS CELL 8P). SAMPLE "(B)(6)" (ANTI-JKA): WHEN TESTED AT CUSTOMER IN DG GEL 8 ANTI-IGG CARDS, ALL PAPAINIZED PANEL JKA+ CELLS REACTED BETWEEN 2+ FOR THE HETEROZYGOUS CELLS (CELL 5P, CELL 8P AND CELL 11P) AND 3+ FOR THE HOMOZYGOUS CELLS (CELL 1P, CELL 6P AND CELL 9P).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2160032 | DATA-CYTE PLUS P 0.8% | REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION | QHT | MEDION GRIFOLS DIAGNOSTICS AG, | N/A | 614025013 | 07640137342272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |