BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABDR SSP UNITRAY KIT

    MDR report key: 3449359 · Received October 10, 2013

    Report

    Report Number
    2244574-2013-00028
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK000019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DISCREPANCY IN INTERNAL SOFTWARE SSP TEST DOCUMENTS RELATING TO PRIMER (B)(4) WAS IDENTIFIED. AS A RESULT, LABELING (AMBIGUITY LIST, UNITRAY AND ASG GEL DOCS, PM TABLES,. UCHFILES AND WORKSHEETS WILL BE CORRECTED. THE UPDATED REVISION WILL INCLUDE THE MIX SPECIFICITY TO REMOVE ALLELES DRB1 11:09, 11:83, 11:89, 11:113, 13:05:02, 13:06, 13:26:02, 13:42, 13:56, AND 13:136 AS POSITIVE. ADDITIONAL INVESTIGATION ACTIVITIES ARE STILL ONGOING AND WILL BE REPORTED IN THE 30-DAY REPORT.

    Description of Event or Problem · 1

    UPON THE INTERNAL INVESTIGATION OF CUSTOMER COMPLAINT RECORD ((B)(4)) IT WAS DETERMINED THAT ONE LOT OF ABDR SSP UNITRAY KIT (CATALOG# 7810010) WAS AFFECTED. IN THE AFFECTED KIT LOTS, THE PRESENCE OF DRB1 13:05 IN A SAMPLE LEADS TO A MISTYPE OF DRB1 13:04 DUE TO A FALSE NEGATIVE RESULT IN LANE 15. THE REACTION PATTERNS FOR THESE TWO ALLELES IS AS FOLLOWS: DRB1 13:05: POSITIVE LANES 10, 11, 15, 26. DRB1 13:04: POSITIVE LANES 10, 11, 26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519976 ABDR SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP. 036 1316325

    Patients

    Seq Age Sex Outcome Treatment
    1