REAGENT RED BLOOD CELLS IH-CELL I-II
Report
- Report Number
- 9610824-2022-00044
- Event Type
- Malfunction
- Date Received
- August 2, 2022
- Date of Event
- July 11, 2022
- Report Date
- October 18, 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 SPECIFICITIES OF THE MISSED ANTIBODIES WERE ANTI-K AND ANTI-LEA. CELL #2 OF IH-CELL I-II WAS K AND LEA ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODIES WERE DETECTED IN THE MANUAL METHOD. THE ANTI-LEA ALSO SHOWED A POSITIVE REACTION IN THE REPEAT TESTING. 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 THE PATIENT SAMPLE FOR INVESTIGATION. 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-K, THREE DIFFERENT ANTI-LEA 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 K HETEROZYGOUS POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH THREE OTHER K ANTIGEN HETEROZYGOUS POSITIVE REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN K HOMOZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL K ANTIGEN HETEROZYGOUS RRBS YIELDED THE SAME TITER. THE TESTING CONFIRMED THAT THE K 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 INSTRUMENT IH-1000 WERE COLLECTED. THE ANALYSIS OF THE 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 IH-1000. THE SPECIFICITIES OF THE MISSED ANTIBODIES WERE ANTI-K AND ANTI-LEA. CELL #2 OF IH-CELL I-II WAS K AND LEA ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODIES WERE DETECTED IN THE MANUAL METHOD. THE ANTI-LEA ALSO SHOWED A POSITIVE REACTION IN THE REPEAT TESTING. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE IH- CELL I-II FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THE PATIENT SAMPLE WAS COMPLETELY HEMOLYZED WHEN IT ARRIVED ON OUR PREMISES. EVEN AFTER CENTRIFUGATION, NO CLEAR BOUNDARY BETWEEN RED BLOOD CELLS AND PLASMA WAS VISIBLE. WHILE WE WERE WAITING FOR THE PATIENT SAMPLES, 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 LOT #9203030. THREE DIFFERENT ANTI-K, THREE DIFFERENT ANTI-LEA WERE USED FOR THE TEST AS WELL AS AN ANTIFYA, ANTI-S AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL ANTIBODIES WERE CORRECTLY DETECTED. ADDITIONALLY, THE ANTIGEN K HETEROZYGOUS POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH THREE OTHER K ANTIGEN HETEROZYGOUS POSITIVE REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN K HOMOZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL K ANTIGEN HETEROZYGOUS RRBS YIELDED THE SAME TITER. THE TESTING CONFIRMED THAT THE K ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT WAS NOT WEAKENED. DUE TO THE HEMOLYSIS OF THE PATIENT SAMPLE #L1050713-BB (MISSED ANTI-K) A TESTING 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.. 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 INSTRUMENT IH-1000 WERE COLLECTED. THE ANALYSIS OF THE MATERIAL SHOWED THAT THE TESTS WERE CORRECTLY PERFORMED. THE VOLUMES DISTRIBUTED WERE FINE. WHEN THE NEGATIVE RESULT OCCURRED THE WAITING TIME WAS A FEW SECONDS. THE RETEST WAS CORRECTLY POSITIVE WHEN THE WAITING TIME WAS 9 MINUTES. BASED ON THE OBSERVED BEHAVIOR (POSITIVE REACTION AFTER A WAITING TIME VERSUS NEGATIVE REACTION WITHOUT WAITING TIME) AN IGM COMPONENT OF THE ANTI-K WAS HIGHLY SUSPECTED. BUT COULD NOT BE CONFIRMED DUE THE HEMOLYSIS OF THE PATIENT SAMPLE IN QUESTION. 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 SAMPLES COULD NOT BE TESTED. COMPARATIVE AND POTENCY TESTS DEMONSTRATED THAT THE K ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT WAS NOT WEAKENED. BASED ON THE OBSERVED BEHAVIOR AN IGM COMPONENT OF THE ANTI-K WAS HIGHLY SUSPECTED AND WOULD BE A REASONABLE EXPLANATION FOR THE NEGATIVE REACTION WITH IH-CELL I-II AT THE CUSTOMER'S SITE. A GENERAL ISSUE WITH THE REAGENT RED BLOOD CELLS AND IH-CARDS COULD BE RULED OUT. THE CAUSE OF THE FALSE-NEGATIVE REACTION OF THE ANTI-LE(A) IN THE CUSTOMER'S FIRST TEST REMAINED UNRESOLVED. DUE TO THE GROSSLY HEMOLYSIS THE PATIENT SAMPLE COULD NOT BE TESTED. THE CORRECT TRACE FILES WERE NOT AVAILABLE; THEREFORE, AN INVESTIGATION OF THE INSTRUMENT WAS NOT POSSIBLE. ON THE SCREEN SHOT WE COULD ONLY OBSERVE A NEGATIVE REACTION. A GENERAL ISSUE WITH THE REAGENT RED BLOOD CELLS AND IH-CARDS COULD BE RULED OUT. COMPARATIVE AND POTENCY TESTS DEMONSTRATED THAT THE LE(A) ANTIGENICITY OF THE CLAIMED IH-CELL I-II LOT WAS NOT WEAKENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1411321 | 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)(6)| IH-1000, SN (B)(6)| IH-ANTI-IGG, LOT 9203030| IH-ANTI-IGG, LOT 9203030 |