BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

Report

Report Number: 9610824-2021-00042
Event Type: Malfunction
Date Received: June 7, 2021
Date of Event: May 14, 2021
Report Date: August 17, 2021
Manufacturer: BIO-RAD MEDICAL DIAGNOSTICS GMBH
Product Code: QHR
UDI-DI: 07611969952090
PMA / PMN Number: 125534
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THIS IS OUR FINAL REPORT ON THIS INCIDENT.

Description of Event or Problem · 0

THE CUSTOMER WAS VALIDATING THEIR INSTRUMENT IH-READER 24 AND REPORTED MANY QUESTIONABLE RESULTS WITH DIFFERENTLY TYPES OF CARDS. AS THE CUSTOMER SAW THIS ISSUE WITH DIFFERENT TYPES OF IH-CARDS, IN TOTAL FOUR (4) COMPLAINTS WERE INITIATED: INV000079523: IH-CARD ABO/D(DVI-)+REV A1,B LOT: 8009100 (THE PRESENT CASE). INV000079650: IH-CARD ABD (DVI+)-CONF LOT: 8043080. INV000079651: IH-CARD AHG ANTI-IGG LOT: 8032010. INV000079947: IH-CARD ABO/RHD (DVI+) LOT: 8034020. A FIELD SERVICE ENGINEER CHECKED THE IH-READER 24. HE CLEANED THE CAMERA LENS AND LIGHTING FILTER. HE PERFORMED TECH TIP IH-023 AND PROCEEDED WITH PM DURING WHICH A FULL SYSTEM CHECKOUT WAS PERFORMED SUCCESSFULLY. A CALIBRATION WAS PERFORMED AND PASSED. THE QC WAS PERFORMED WITH NO IRREGULARITIES. THE SCREENSHOTS THE CUSTOMER PROVIDED LOOKED FINE BASED ON VALUE ADJUSTMENTS AND AZIMUTH. THE CUSTOMER HAS NOT BEEN ABLE TO PERFORM ANY ADDITIONAL TESTING DUE TO STAFFING SHORTAGES. THE PROVIDED DAILY JOURNAL SHOWED THAT USING THE IH-INTERNAL QC SAMPLE 2, THAT IS EXPECTED TO BE O RHD NEGATIVE, THE IH-COM GRADED VISUALLY CLEAR NEGATIVE REACTIONS IN THE ANTI-A AS WELL AS ANTI-B WELL WITH A "NOT INTERPRETABLE (1+)" RESULT. FOR THE COMPLAINT INVESTIGATION OF THE IH-CARD ABO/D(DVI-)+REV A1,B THE FOLLOWING SAMPLES WERE USED: IH-INTERNAL QC SAMPLE 1,2,3 AND 4 LOT: 780200102 FROM QC STOCK AS WELL AS LOT: 780200103 AS THE CUSTOMER MENTIONED THAT THE OCCURRENCE OF QUESTIONABLE RESULTS IS MARKEDLY REDUCED WHEN THE PIPETTED CARDS ARE IMMEDIATELY PLACED IN THE IH-READER 24 COMPARED TO SIT FOR A FEW MINUTES ON THE BENCH PRIOR THE CENTRIFUGATION, THE COMPLAINT INVESTIGATION TESTING WAS PERFORMED IN THE FOLLOWING WAY: 1. CENTRIFUGATION OF PIPETTED CARDS IMMEDIATELY AFTER PIPETTING OF RED CELLS AND ANTISERA. 2. ALLOW PIPETTED CARDS TO SIT FOR 6 MINUTES PRIOR TO CENTRIFUGATION. IN ORDER TO SIMULATE A POSSIBLE FURTHER INTERRUPTION DURING ROUTINE TESTING AT CUSTOMER SITE THE FOLLOWING WORKFLOW WERE ADDITIONALLY PERFORMED: 3. PREPARATION OF RED BLOOD CELL SUSPENSION IN IH-LISS AND STORAGE FOR 24 HOURS PRIOR TO PIPETTING, ALLOW TO SIT FOR 15 MINUTES PRIOR TO CENTRIFUGATION. EACH WELL WAS GRADED CORRECTLY NEGATIVE OR POSITIVE BY THE IH-READER 24 CORRESPONDING TO THE SAMPLE USED. WE DID NOT OBSERVE ANY DISCREPANCIES OR QUESTIONABLE RESULTS. FURTHERMORE, THE TEST APPROACH TO ALLOW PIPETTED CARDS SIT FOR UP TO 15 MINUTES REVEALED NO INDICATION FOR A POSSIBLE CAUSE OF QUESTIONABLE RESULT INTERPRETATION BY THE INSTRUMENT. BASED ON THE IMAGES THE CUSTOMER PROVIDED THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UNEXPECTED PRODUCT PERFORMANCE (UPP). HOWEVER, THE COMPLAINT INVESTIGATION DID NOT REVEAL INFORMATION SUGGESTING THAT THERE IS HIGH OCCURRENCE OF QUESTIONABLE RESULTS WITH GEL CARDS USED WITH THE IH-READER 24. IN ADDITION, SOME INTERRUPTION DURING THE TEST PROCEDURE SEEMS NOT TO HAVE AN INFLUENCE ON THE RESULT INTERPRETATION OF THE IH-READER 24. WE WOULD ALSO LIKE TO REFER TO THE FOLLOWING INFORMATION FROM THE IFU: "ONCE THE FOIL HAS BEEN REMOVED FROM THE MICROTUBES, TESTING MUST BE INITIATED TO PREVENT DRYING OF THE GEL". DUE TO THE SMALL AMOUNT OF SAMPLE MATERIAL PIPETTED IN THE REACTION CHAMBER EVAPORATION AND DEHYDRATION PROCESSES HAVE TO BE TAKEN INTO ACCOUNT DURING THE MANUAL TESTING, ESPECIALLY IN THE SURROUNDING OF CEILING VENTS AND AIR CONDITIONING. THE TECHNICIAN INTERVENTION SEEMED TO HAVE BEEN SUCCESSFUL. DUE TO LACK OF CAPACITY, THE CUSTOMER COULD NOT CONTINUE THE VALIDATION. THEREFORE, A FINAL CONFIRMATION THAT THE DEVICE WORKED ACCORDING TO SPECIFICATIONS WAS MISSING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

Additional Manufacturer Narrative · 1

THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

Description of Event or Problem · 1

THE CUSTOMER IS CURRENTLY VALIDATING THEIR INSTRUMENT IH-READER 24 AND REPORTS MANY QUESTIONABLE RESULTS WITH DIFFERENTLY TYPES OF CARDS. THE PROVIDED DAILY JOURNAL SHOWED THAT USING THE IH-INTERNAL QC SAMPLE 2, THAT IS EXPECTED TO BE O RHD NEGATIVE, THE IH-COM GRADED VISUALLY CLEAR NEGATIVE REACTIONS IN THE ANTI-A AS WELL AS ANTI-B WELL WITH A 1+ RESULT. FURTHERMORE, THE CUSTOMER MENTIONED THAT THE OCCURRENCE OF QUESTIONABLE RESULTS IS MARKEDLY REDUCED IF THE PIPETTED CARDS ARE IMMEDIATELY PLACED AND CENTRIFUGED IN THE IH-READER 24. IF THE PIPETTED CARDS SIT FOR A FEW MINUTES ON THE BENCH PRIOR THE CENTRIFUGATION THE NUMBER OF QUESTIONABLE RESULTS INCREASE. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. TESTING OF OUR QUALITY CONTROL LABORATORY'S RETENTION SAMPLE IS STILL ONGOING. INVESTIGATION OF THE AFFECTED IH-READER IS ALSO ONGOING. 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
847675	BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B	IH-CARD ABO/D(DVI-)+REV A1,B; 48 CARDS	QHR	BIO-RAD MEDICAL DIAGNOSTICS GMBH		8009100	07611969952090

Patients

Seq	Age	Sex	Outcome	Treatment
1				IH-CARD ABD (DVI+)-CONF LOT: 8043080\| IH-CARD ABO/RHD (DVI+) LOT: 8034020\| IH-CARD AHG ANTI-IGG LOT: 8032010\| IH-READER, SN (B)(6)\| IH-READER, SN (B)(6)\| IH-READER, SN (B)(4)