BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10612126 · Received October 1, 2020

    Report

    Report Number
    9610824-2020-00067
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 3, 2020
    Report Date
    November 4, 2020
    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
    CA, 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 DOUBLE POPULATION IN THE CONTROL WELL AND A 1+ FALSE POSITIVE REACTION IN THE ANTI-B WELL OF IH-CARD ABO/D(DVI-)+REV.A1, B (REF #813112100, LOT #8014070) ON IH-500. THE DOUBLE POPULATION OCCURRED WITH CONTROL 2 OF IH-BASIC QC KIT AND PATIENT SAMPLES. THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT RESPECTIVELY THE CONTROL KIT WHICH HAD CAUSED FALSE POSITIVE RESULTS RESPECTIVELY DOUBLE POPULATION RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH 30 DONOR SAMPLES ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. IN SEVEN CASES QUESTION MARK RESULTS WERE OBSERVED IN THE CONTROL WELL WHICH WERE VISUALLY ASSESSED CLEARLY NEGATIVE. IN A RETEST THE QUESTION MARK RESULTS DID NOT REOCCUR ANYMORE. WE DID NEITHER OBSERVE ANY FALSE POSITIVES NOR DOUBLE POPULATION. THE TECHNICAL SUPPORT REPRESENTATIVE WENT ON SITE TO CHECK THE AFFECTED IH-500 AND NOTICED THAT THE CARDS WERE NOT SPUN DOWN CAUSING THE CARRY OVER. AFTER THE CARDS WERE SPUN DOWN THE SYSTEM WAS WORKING FINE. BASED ON THE STATEMENT OF THE TECHNICAL SUPPORT REPRESENTATIVE THE ISSUE WAS SOLVED AFTER THE CARDS WERE CENTRIFUGED BEFORE THEY WERE PROCESSED ON THE IH-500 ACCORDING TO THE INSTRUCTION FOR USE. THE RETENTION SAMPLE MET THE ACCEPTANCE CRITERIA. 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 REPORTED A FALSE POSITIVE RESULT OF A PATIENT SAMPLE WITH THE ANTI-B OF IH-CARD ABO/D(DVI-)+REV.A1, B WHEN TESTED ON IH-1000. BECAUSE OF THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE", AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT. TESTING OF THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. ALSO AN INVESTIGATION OF THE INSTRUMENT FILES 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078446 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1, IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8014070 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-500, #5500029| IH-500, #5500029| IH-500, #5500029