BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS ERYTYPECELL A1 & B

    MDR report key: 2220644 · Received July 10, 2011

    Report

    Report Number
    9610824-2011-00088
    Event Type
    Malfunction
    Date Received
    July 10, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSF
    PMA / PMN Number
    125208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED MISSED ISOAGGLUTININS WITH B REAGENT RED BLOOD CELLS OF ERYTYPE A1 AND B AT A (B)(6) FEMALE ONCOLOGY PT WITH BLOOD GROUP A ON TANGO TESTING. THE PROVIDED PT SAMPLE WAS TESTED IN OUR QC AB ON TANGO OPTIMO WITH ERYTYPE S ABD+ REV A1, B AND THE COMPLAINED LOT 8119011 OF ERYTYPECELL A1 AND B. THIS PERFORMANCE CONFIRMED THE REACTION DESCRIBED BY THE CUSTOMER. FOR BLOOD GROUP A THE QC COULD NOT DETECT ISOAGGLUTININS AGAINST THE B REAGENT RED BLOOD CELLS. THE CARRIED WHOLE BLOOD CONTROLS REACTED AS EXPECTED. FURTHERMORE THE SAMPLE WAS TESTED IN THE 3-PHASE-TUBE TEST AND THE ISOAGGLUTININS ANTI-B FROM THE PT SAMPLE REACTED VERY WEAK POSITIVE DURING THE FIRST STEP (IS). ONLY AT 4 DEGREES CELSIUS A STRONGER REACTION STRENGTH COULD BE OBSERVED. THE AGGLUTINATIONS OF THE TUBE TESTS WERE VERY FRAGILE. IN THE INSTRUCTIONS FOR USE POINT LIMITATION THE CUSTOMER CAN FIND THE HINT FOR ELDERLY PTS THE ISOAGGLUTININS MAY BE ABSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS ERYTYPECELL A1 & B ERYTYPECELL A1&B KSF BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR TANGO OPTIMO: SERIAL NO (B)(6)| IMMUCOR B CELLS: LOT 113814, EXP 7/1/2011| ERYTYPE ABDREV PLATE: LOT 7012010, EXP 9/18/2011