BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL REVERSE BLOOD GROUPING CARD

    MDR report key: 1860732 · Received October 7, 2010

    Report

    Report Number
    1056600-2010-00122
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING OF THE GEL CARDS AND A BATCH RECORD REVIEW. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FALSE NEGATIVE REACTIONS WERE OBSERVED WITH A PATIENT SAMPLE THAT RESULTED AS TYPE O IN THE FORWARD GROUPING BUT RESULTED AS TYPE A IN THE REVERSE GROUPING. TESTING WAS REPEATED WITH THE SAME RESULTS. PER INTERNAL POLICY, THE SAMPLE WAS SENT TO THE REFERENCE LAB FOR CONFIRMATION USING TUBE METHOD. THE REFERENCE LAB REPORTED THE SAMPLE TO BE GROUP O, WITH NO ISSUES. DAILY QC WAS ACCEPTABLE. ALL LISTED PRODUCTS HAVE BEEN STORED AS PER PACKAGE INSERTS AND APPEAR NORMAL BEFORE USE. ALL OTHER SAMPLES TESTED HAVE RESULTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS A/B/D MONOCLONAL REVERSE BLOOD GROUPING CARD BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1