BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B17 SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3704991 · Received January 15, 2014

    Report

    Report Number
    2244574-2014-00061
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Report Date
    May 31, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Removal / Correction Number
    006-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION HAS CONFIRMED THAT PRIMER MIX B-086 FOUND ON LANE 9 IN THE B17 SSP UNITRAY KIT WITH TAQ POLYMERASE (CATALOG #472313 LOT #004 825654 903448) WILL GIVE A FALSE NEGATIVE FOR THE B 47:03 ALLELE IN THE AFFECTED PRODUCT ACCORDING TO THE LABELING. THE LABELING STATED THE PRIMERS IN PRIMER MIX B-086 WOULD AMPLIFY THIS SEQUENCE IN THE B 47:03 ALLELE. ROOT CAUSE HAS BEEN DETERMINED TO BE PRODUCT DESIGN (INCORRECT LABELING).

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(4) THAT A SURVEY SAMPLE TESTED WHEN USING B LOCUS HIGH RES SSP UNITRAY KIT (CATALOG #4730010, LOT #009 984375) RESULTED IN B 47:02 WHEN THE RESULT SHOULD HAVE BEEN B 47:03 ((B)(4)). CATALOG #472313 B17 SSP UNITRAY KIT WITH TAQ POLYMERASE, LOT #004 825654 903448 HAS BEEN IDENTIFIED AS PRODUCT THAT WOULD BE AFFECTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41863 B17 SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-D MZI LIFE TECHNOLOGIES CORPORATION 004 825654 903448

    Patients

    Seq Age Sex Outcome Treatment
    1