BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11705258 · Received April 22, 2021

    Report

    Report Number
    9610824-2021-00021
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Report Date
    July 21, 2021
    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
    NY, 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 REPORTED THAT VISUALLY CLEARLY NEGATIVE RESULTS WERE EVALUATED BY THEIR IH1000 AS 1+ POSITIVE. ACCORDING TO THE CUSTOMER MAINLY THE ANTI-A WELL WAS AFFECTED. THE EXACT DATE OF OCURRENCE IS NOT KNOWN. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE IH-CARD ABO/D(DVI-)+REV.A1, B (REF #813 112 100, LOT #8033010) FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. OUR QUALITY CONTROL LABORATORY ALSO TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON IH-1000. BLOOD GROUPS A AND O WERE MAINLY USED. TWO SAMPLES WERE RATED 1+ BY IH-1000 ALTHOUGH THEY WERE CLEARLY NEGATIVE VISUALLY. BOTH SAMPLES WERE THEN TESTED IN A FIVE REPLICATE TO VERIFY THAT THE 1+ RESULTS WERE REPRODUCIBLE. ALL WELLS WERE INTERPRETED CORRECTLY AND NO 1+ RESULTS OCCURRED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED IH-1000, THE TRACE FILES AND IMAGES WERE ANALYZED AND ALSO BOTH FALSE POSITIVE WELLS. LIKE AT THE CUSTOMER'S SITE, THE FALSE POSITIVE TEST RESULTS WERE CAUSED BY UNCENTERED WELLS. AS A RESULT, PARTS OF THE WALL OF THE WELL WERE INCLUDED IN THE WELL INTERPRETATION BY THE SOFTWARE. THIS ISSUE IS ALREADY ADDRESSED IN THE TIER I CAPA QN500036573.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INTIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN USING IH-CARD ABO/D(DVI-)+REV.A1, B ON THE IH-1000 INSTRUMENTS, VISUALLY CLEARLY NEGATIVE RESULTS WERE EVALUATED BY IH-1000 AS 1+ POSITIVE. THE CUSTOMER DID NOT PROVIDE AN EXACT DATE OF EVENT BUT DESCRIBED THE ISSUE AS ONGOING, APPROX. 2 TO 5 TIMES A DAY. THE GREAT MAJORITY OF THE TIME THE ISSUE OCCURS IS IN THE FIRST COLUMN, SO ANTI-A OR CELL 1 OF AN ANTIBODY SCREEN. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE IH-CARD ABO/D(DVI-)+REV.A1, B (REF #813 112 100, LOT #8033010) FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON IH-1000. THE INVESTIGATION IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. INVESTIGATION OF THE INSTRUMENT'S DATA IS ALSO STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604715 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 8033010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, SN (B)(6).| IH-1000, SN (B)(6).| IH-1000, SN (B)(6).| IH-1000, SN (B)(6).