BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD SSP HLA DQ LOW RES KIT

    MDR report key: 3558177 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00065
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK070038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALLSET GOLD SSP HLA DQ LOW RES KIT (CATALOG #54390D), LOT # 004 1139386, JANUARY 2013, ALLELE UPDATE KIT DATABASE INCLUDED INCORRECT SEROLOGIC EQUIVALENT INFORMATION. IT WAS DETERMINED THAT THE ALLELE UPDATE DOCUMENTS FOR MULTIPLE KITS WERE IMPACTED. APPROXIMATELY 1300 SEROLOGICAL EQUIVALENTS WERE FOUND TO BE MISSING FROM THE HOS DATABASE. CORRECTED JANUARY 2013, ALLELE UPDATE DOCUMENTS WERE CREATED AFTER HOS SEROLOGIC EQUIVALENT DATA WAS RESTORED. CUSTOMER NOTIFICATION ISSUED ON APRIL 18, 2013. NO ROOT CAUSE WAS DETERMINED. SCAR TO IT SEE (B)(4) IT IMPLEMENTING DATABASE TRACKING AS MITIGATION. EFFECTIVITY CHECK SEE (B)(4). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE INITIAL AND FINAL MDR.

    Description of Event or Problem · 1

    CUSTOMER NOTED A DIFFERENCE IN SEROLOGIC EQUIVALENT INFORMATION IN THE 3.11.0 JANUARY 2013 ALLELE UPDATE UNIMATCH DATABASE INFORMATION FOR ALLSET GOLD SSP HLA DQ LOW RES KIT (CATALOG #54390D), LOT # 037 1229595. CUSTOMER COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529216 ALLSET GOLD SSP HLA DQ LOW RES KIT MZI LIFE TECHNOLOGIES CORP. 037 1229595

    Patients

    Seq Age Sex Outcome Treatment
    1