BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3413658 · Received September 25, 2013

    Report

    Report Number
    2244574-2013-00018
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Report Date
    April 25, 2012
    Manufacturer
    LIFETECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION INCLUDED A REVIEW OF THE RELEASE TESTING RESULTS FOR THIS BATCH. THE INVESTIGATION CONFIRMED THAT MIX HAD NOT BEEN TESTED WITH A B 47:03 ALLELE ON (B)(6) 2012. LAB RESULTS WERE ANALYZED ON (B)(4) 2012 AND LANE 83 WAS NOT PRESENT IN RESULT. THIS REPORT WAS ASSEMBLED, AS WAS THE GEL DOCUMENT WITH ANALYSIS AND THE TEST RECORD. LABELING WAS CORRECTED AND NOTIFICATION WAS PROVIDED TO CUSTOMERS AND WAS REPORTED TO THE RECALL COORDINATOR ON JULY 27, 2012. THIS MDR REPORT WILL SERVE AS THE INITIAL AND FINAL REPORT. AFFECTED LOTS OF B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLYMERASE (CATALOG # 4730110): LOT # 009 984375 1077181, MFG. DATE: 10/2011, EXP. DATE: 03/2013 - MFR 2244574-2014-00128; LOT #: 009 984375 1112028, MFG. DATE: 01/2012, EXP. DATE: 12/2012 - MFR 2244574-2014-00129; LOT #: 009 984375 1112356, MFG. DATE: 01/2012, EXP. DATE: 03/2013 - MFR 2244574-2013-00018; LOT #: 009 984375 1113862, MFG. DATE: 01/2012, EXP. DATE: 03/2013 - MFR 2244574-2014-00130.

    Description of Event or Problem · 1

    (B)(6) REPORTED THAT A SURVEY SAMPLE TESTED USING WHEN USING B LOCUS HIHG RES SSP UNITRAY KIT WITH TAQ POLYMERASE (CATALOG # 4730110, LOT # 009 984375) RESULTED IN B 47:02 WHEN THE RESULT SHOULD HAVE BEEN B 47:03 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485720 B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLYMERASE MZI LIFETECHNOLOGIES CORP. 009 984375 1071655

    Patients

    Seq Age Sex Outcome Treatment
    1