BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14695189 · Received June 15, 2022

    Report

    Report Number
    9610824-2022-00030
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A 1+ RESULT INSTEAD OF A CLEARLY NEGATIVE RESULT WITH THE ANTI-D OF THE IH-CARD ABO/D(DVI-)+REV A1,B ON IH-1000. THE CUSTOMER OBSERVED THIS ISSUE WITH THE HEMOBIOSCIENCE CONTROL (HBC) #3. THIS CONTROL WAS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER ANNOUNCED TO SEND IN HIS PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LABORATORY AWAITED THE COMPLAINT SAMPLE, THEIR RETENTION SAMPLE WAS TESTED ON THE IH-1000. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY QUESTION MARK RESPECTIVELY FALSE POSITIVE RESULTS WITH THE ANTI-D OF THE IH-CARD ABO/D(DVI-)+REV A1,B. AFTER OUR QUALITY CONTROL LABORATORY RECEIVED THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT, IT WAS VISUALLY CHECKED IN PARALLEL WITH THE RETENTION SAMPLE. THE IH-CARDS WERE CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. DUE TO THE COMPLAINT CAUSE FURTHER TESTS WERE PERFORMED ON THE IH-1000: 9 D- ANTIGEN NEGATIVE DONOR SAMPLES, 1 D-ANTIGEN POSITIVE DONOR SAMPLE AND THE HBC #3 WERE TESTED WITH THE RETENTION SAMPLE. PRIOR TO TESTING HBC #3 WAS CENTRIFUGED FOR 10 MINUTES AT 2000 X G. ONE RESULT IN THE ANTI-D WELL WAS ASSESSED AS QUESTION MARK. THIS ASSESSMENT WAS CORRECT DUE TO SOME SMALL RED DOTS / AGGLUTINATES IN THE GEL COLUMN. · HBC #3 (RHD NEGATIVE) WAS TESTED SIX TIMES WITH THE COMPLAINT SAMPLE. PRIOR TO TESTING HBC #3 WAS CENTRIFUGED 10 MINUTES AT 2000 X G. TWO REACTIONS RESULT IN THE ANTI-D WELLS WERE ASSESSED AS 1+ POSITIVE. THIS ASSESSMENT WAS CORRECT DUE TO SOME SMALL RED DOTS / AGGLUTINATES. THE OTHER GEL COLUMNS WERE EVALUATED AS NEGATIVE BOTH VISUALLY AND BY THE IH-1000. SINCE IT WAS SUSPECTED THAT THE QUESTIONABLE RESPECTIVELY FALSE POSITIVE REACTIONS OCCURRED EXCLUSIVELY WITH THE HBC #3, IT WAS WASHED SEVERAL TIMES AND THEN RETESTED WITH THE CUSTOMER CARDS IN FIVE TIMES DETERMINATION. TWO REACTIONS IN THE ANTI-D WELLS WERE ASSESSED AS 1+ POSITIVE AND ONE REACTION AS QUESTION MARK. THIS ASSESSMENTS WERE CORRECT DUE TO SOME SMALL RED DOTS / AGGLUTINATES. THE OTHER GEL COLUMNS WERE EVALUATED AS NEGATIVE BOTH VISUALLY AND BY THE IH-1000. BASED ON THE PICTURE THE CUSTOMER PROVIDED THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP (UNEXPECTED PRODUCT PERFORMANCE). WHEN WE TESTED THE AFFECTED CARD WITH SAMPLES, THE TEST RESULTS WERE AS EXPECTED. THE FALSE POSITIVE RESPECTIVE QUESTION MARK RESULTS WERE ONLY OBTAINED WHEN USED WITH THE HEMOBIOSCIENCE CONTROL (HBC) # 3. IN SOME CASES WE ALSO OBSERVED RED BLOOD CELL RESIDUES ON THE LEFT SIDE OF GEL COLUMN. THESE RESULTS WERE ONLY OBSERVED WITH THE HEMOBIOSCIENCE CONTROL HBC #3, BUT NOT WITH DONOR SAMPLES. HOWEVER, THE SECTION INTERPRETATION OF RESULTS OF THE INSTRUCTION FOR USE CONTAINED THE FOLLOWING NOTE: "A VERY WEAK REACTION IS NOT AN EXPECTED RESULT FOR ANTIGEN TESTING. IT MAY INDICATE THAT A FALSE POSITIVE OR A VERY WEAK/PARTIAL EXPRESSION OF THE ANTIGEN IS PRESENT. FURTHER INVESTIGATION OF THIS SAMPLE SHOULD BE PERFORMED BEFORE THE ANTIGEN STATUS IS DETERMINED." A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BUT DUE TO THE ISSUE OF THE HEMOBIOSCIENCE CONTROL AND THE IH-CARD OBSERVED AT THE CUSTOMER'S SITE WE INITIATED FURTHER ACTIONS WITH THE EFFORT TO FIND THE ROOT CAUSE AND SOLVE THE PROBLEM. THIS ACTIVITY WAS DOCUMENTED IN (B)(4). TRACE FILES OF THE AFFECTED IH-1000 WERE INVESTIGATED. NO INDICATION FOR A MALFUNCTION COULD BE FOUND. INITIALLY, THE CUSTOMER FILED HIS COMPLAINT ONLY A QUESTION MARK RESULT, WHICH WAS INTERNALLY CATEGORIZED AS NOT MEETING THE CRITERIA OF A MEDICAL DEVICE REPORT. DURING THE INVESTIGATION, IT BECAME APPARENT THAT NOT ONLY QUESTION MARK RESULT WAS OBTAINED, BUT ALSO ONE FALSE POSITIVE TEST RESULT. BY THEN. THE TIMELINE OF 30 DAYS HAS ALREADY BEEN EXCEEDED. AN INTERNAL QUALITY NOTIFICATION WAS RAISED AGAINST THIS VIOLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627927 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9147030 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEMOBIOSCIENCE CONTROL (HBC) # 3.| IH-1000, SN (B)(4).