REAGENT RED BLOOD CELLS IH-CELL I-II
Report
- Report Number
- 9610824-2022-00042
- Event Type
- Malfunction
- Date Received
- August 2, 2022
- Date of Event
- July 5, 2022
- Report Date
- October 13, 2022
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- QHT
- UDI-DI
- 07611969952274
- PMA / PMN Number
- 125208
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS IS OUR INITIAL REPORT ON THIS INCIDENT.
THIS IS OUR FINAL REPORT ON THIS INCIDENT.
THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH IH-CELL I-II ON IH-1000. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. CELL #2 OF IH-CELL I-II WAS E ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODY WAS DETECTED IN THE MANUAL METHOD. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE IH-CELL I-II FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. BUT SHE ANNOUNCED TO SHIP A PATIENT SAMPLE. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE TESTING WAS PERFORMED USING IH-CARD AHG ANTI-IGG LOT #9203030, THE SAME LOT CUSTOMER HAD USED. THREE DIFFERENT ANTI-E WERE USED FOR THE TEST AS WELL AS AN ANTI-FYA, ANTI-S AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL ANTIBODIES WERE CORRECTLY DETECTED. ADDITIONALLY, THE ANTIGEN E POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH TWO OTHER ANTIGEN E HOMOZYGOUS REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN E HETEROZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL E ANTIGEN HOMOZYGOUS RRBS YIELDED THE SAME TITER. THE TESTING CONFIRMED THAT THE E ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT WAS NOT WEAKENED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. DATABASES AND LOG FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE PROVIDED. THE ANALYSIS OF THE RECEIVED MATERIAL FOR ANY ISSUE RELEVANT ANOMALIES IS STILL ONGOING.
THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH IH-CELL I-II ON THE IH-1000. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. CELL #2 OF IH-CELL I-II WAS E ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODY WAS DETECTED IN THE MANUAL METHOD. THE CUSTOMER DID NOT PROVIDE THE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-CELL I-II FOR INVESTIGATIONAL TESTING BUT PATIENT SAMPLES THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULTS. THE PATIENT SAMPLES WERE COMPLETELY HEMOLYZED. EVEN AFTER CENTRIFUGATION, NO CLEAR BOUNDARY BETWEEN RED BLOOD CELLS AND PLASMA WAS VISIBLE. WHILE WE WERE WAITING FOR THE PATIENT SAMPLES TO ARRIVE ON OUR PREMISES, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE TESTING WAS PERFORMED USING IH-CARD AHG ANTI-IGG LOT #9203030, THE SAME LOT CUSTOMER HAD USED. ADDITIONALLY, THE CUSTOMER HAD RETURNED NINE PROCESSED IHCARDS AHG ANTI-IGG OF THIS LOT. THREE DIFFERENT ANTI-E WERE USED FOR THE TEST AS WELL AS AN ANTI-FYA, ANTI-S AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL ANTIBODIES WERE CORRECTLY DETECTED. ADDITIONALLY, THE ANTIGEN E POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH (B)(4) OTHER ANTIGEN E HOMOZYGOUS REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN E HETEROZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL E ANTIGEN HOMOZYGOUS RRBS YIELDED THE SAME TITER. THE TESTING CONFIRMED THAT THE E ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT IS NOT WEAKENED. DUE TO THE HEMOLYSIS OF THE PATIENT SAMPLES A TESTING OF THE SAMPLES WAS NOT POSSIBLE. THE PROCESSED IH-CARDS FORWARDED BY CUSTOMER COULD NOT BE ANALYZED, BECAUSE THE GEL COLUMNS WERE COMPLETELY DRIED OUT DUE TO THE LACK OF THE SEALING FOIL. THE ANALYSIS OF THE DATA FILES OF THE AFFECTED IH-1000 INSTRUMENT SHOWED THAT THE TRACE FILES FOR THE DATE OF EVENT WERE NOT AVAILABLE, ONLY A SCREEN SHOT OF THE DAILY JOURNAL. ON THE SCREEN SMALL AGGLUTINATES WERE VISIBLE ABOVE THE PELLET. WE COULD ONLY SUSPECT THAT THE ALGORITHM IMAGE ANALYSES IDENTIFIED A FEW AGGLUTINATIONS ABOVE THE PELLET /CELL II) BUT NOT ENOUGH TO BE CONSIDERED AS A WEAK POSITIVE REACTION. DUE TO THE LACK OF DATA, FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION AND THE RETENTION SAMPLE REACTED AS EXPECTED. DUE TO THE GROSSLY HEMOLYSIS THE PATIENT SAMPLE COULD NOT BE TESTED. COMPARATIVE AND POTENCY TESTS DEMONSTRATED THAT THE E ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT WAS NOT WEAKENED. THE CUSTOMER INFORMED US THAT THE ANTI-E SAMPLE REACTED WITH A STRONG 1+ POSITIVE REACTION IN A REPEAT TESTING ON JULY 15 ON BOTH INSTRUMENTS 5100086 AND 5100084 AND ON MANUAL GEL. THE CAUSE OF THE FALSE-NEGATIVE REACTION IN THE CUSTOMER'S FIRST TEST REMAINES UNRESOLVED. A GENERAL ISSUE WITH THE REAGENT RED BLOOD CELLS AND IH-CARDS COULD BE RULED OUT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1553166 | REAGENT RED BLOOD CELLS IH-CELL I-II | IH-CELL I-II; 2X10 ML (REAGENT RED BLOOD CELLS FORMULATED FOR USE IN AUTOMATED | QHT | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 9222011 | 07611969952274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | IH-1000, SN (B)(4)| IH-1000, SN (B)(4)| IH-1000, SN (B)(4)| IH-CARD AHG ANTI-IGG LOT #9203030 |