BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG CARD

    MDR report key: 729108 · Received November 17, 2005

    Report

    Report Number
    1056600-2005-00129
    Event Type
    Malfunction
    Date Received
    November 17, 2005
    Date of Event
    October 17, 2005
    Manufacturer
    MICRO TYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. MTS VERIFIED THE CUSTOMER'S COMPLAINT. MTS COULD NOT RULE OUT ANTI-FYA AND ANTI-E WAS NOT DETECTED. INCIDENT IS MOST LIKELY SAMPLE RELATED. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF THE INVESTIGATION. MTS CANNOT RULE OUT GEL CARD MALFUNCTION AS A CONTRIBUTING FACTOR. LABELING CAUTIONS THE USE AS FOLLOWS: FALSO POSITIVE OR FALSE NEGATIVE TEST RESULTS MAY OCCUR FROM BACTERIAL OR CHEMICAL CONTAMINATION OF TEST MATERIALS, INADEQUATE INCUBATION TIME OR TEMPERATURE, IMPROPER CENTRIFUGATION, IMPROPER STORAGE OF MATERIALS, OR OMISSION OF TEST SAMPLES. OPTIMAL REACTION CONDITIONS VARY ACROSS ANTIBODY SPECIFICITIES. NO SINGLE TEST METHOD WILL DETECT ALL ANTIBODIES. IN SOME LOW IONIC STRENGTH TEST SYSTEMS, CERTAIN ANTIBODIES HAVE BEEN REPORTED TO BE NONREACTIVE. A BATCH RECORD REVIEW INDICATED LOT MET ALL SPECIFICATIONS, IN PROCESS AND LOT RELEASE CRITERIA. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. DISCREPANCIES OBSERVED BETWEEN TUBE AND GEL WAS MOT LIKELY DUE TO DIFFERENCES IN METHODOLOGIES. THE DIFFERENCES BETWEEN GEL AND TUBE ARE NOT UNEXPECTED, SINCE THESE TEST METHODS ARE KNOWN TO EXHIBIT DIFFERENT PATTERNS OF REACTIVITY AND SENSITIVITY DEPENDING ON THE SPECIFIC ANTIBODY. THEREFORE, MTS IS UNABLE TO RULE OUT THE GLE CARD AS THE ROOT CAUSE FOR THE FALSE NEGATIVE RESULTS OBSERVED. IF A SIGNIFICANT ANTIBODY IS NOT DETECTED DURING ANTIBODY SCREENING, OR IS NOT IDENTIFIED UPON FURTHER TESTING, THE PATIENT MAY BE TRANSFUSED WITH ANTIGEN-POSITIVE BLOOD AND SUFFER A HEMOLYTIC TRANSFUSION REACTION.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY RECEIVED A FALSE NEGATIVE REACTION WITH A SAMPLE CONTAINING ANTI-E USING MTS ANTI-IGG CARD, LOT # 071005001-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other