BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM

    MDR report key: 6656150 · Received June 21, 2017

    Report

    Report Number
    9610824-2017-00041
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 21, 2017
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969965670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE CONTROL WITH ANTI-B ON ERYTYPE S ABO CONFIRM WHEN USED ON TANGO INFINITY. THE CUSTOMER USED THE CONTROL REAGENTS (CONTROL 1, 2 AND 3) OF HEMOBIOSCIENCE. CONTROL 2 IS SUPPOSED TO BE BLOODGROUP O RH(D) POS, BUT IT YIELDED THE RESULT BLOODGROUP B RH(D) POS ON ERYTYPE S ABO CONFIRM ON TANGO INFINITY. AFTER CLEANING AND RINSING THE INSTRUMENT CUSTOMER REPEATED THE TESTING WITH THE SAME REAGENTS AND YIELDED CORRECT RESULTS. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT THE CONTROL THAT HAD CAUSED A FALSE POSITIVE TEST RESULT: CONTROL 1, 2 AND 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ERYTYPE S ABO CONFIRM WITH THE CONTROLS ON TANGO INFINITY. THE CONTROLS REACTED AS EXPECTED. ADDITIONALLY THE RETENTION SAMPLE WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE RED BLOOD CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABO CONFIRM FUNCTIONS CORRECTLY. 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
    439327 BLOOD GROUPING REAGENT ERYTYPE® S ABO CONFIRM ERYTYPE S ABO CONFIRM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8641140 07611969965670

    Patients

    Seq Age Sex Outcome Treatment
    1