BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 3183014 · Received June 21, 2013

    Report

    Report Number
    1056600-2013-00034
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING, BATCH RECORD REVIEW, AND A COMPLAINT BY LOT REVIEW WAS PERFORMED. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A (B)(6) PATIENT WITH NO PRIOR HISTORY, BUT LATER DETERMINED TO BE GROUP B RH POSITIVE, WAS FIRST TESTED BY MANUAL GEL METHOD WITH AN ABD/REVERSE GEL CARD AND A 1+ REACTION WAS OBSERVED IN THE D MICROWELL. DUE TO THE WEAK RESULT, CUSTOMER PROCEEDED TO TEST THE SAME PATIENT SAMPLE BY TUBE METHOD WITH A COMPETITOR REAGENT AND THE RESULT WAS NEGATIVE AT IMMEDIATE SPIN AND THEN 2+ AT IAT PHASE. CUSTOMER RETESTED THE SAME PATIENT SAMPLE WITH A DIFFERENT LOT OF ABD/REVERSE GEL CARDS AND A NEGATIVE RESULT WAS OBSERVED. THE CUSTOMER THEN PROCEEDED TO TEST THE SAME PATIENT SAMPLE USING A THIRD LOT OF GEL CARDS AND THE REACTION FOR THE D MICROWELL WAS REPORTED TO BE 2+. CUSTOMER VISUALLY INSPECTED THE CARDS PRIOR TO USE AND OBSERVED THEY WERE ACCEPTABLE. ALL TESTING WAS DONE AT IMMEDIATE SPIN, WITH NO INCUBATION. ALL QC HAS PASSED WITHOUT ISSUES. DURING TROUBLESHOOTING OF THE ISSUE, IT WAS DETERMINED THAT THE CUSTOMER DID NOT FOLLOW THE IFU FOR PREPARING THE RED CELL CONCENTRATIONS. HOWEVER, THE CUSTOMER REPEATED THE TESTING FOLLOWING THE IFU AND STILL NO REACTIVITY WAS OBSERVED. CUSTOMER THEN PERFORMED ADDITIONAL TESTING WITH A REPLACEMENT LOT OF PRODUCT. A 1+ REACTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283194 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD BLOOD GROUPING REAGENT KSZ MICROTYPING SYSTEMS 013013037-21

    Patients

    Seq Age Sex Outcome Treatment
    1