BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABDRDQ SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3560775 · Received November 6, 2013

    Report

    Report Number
    2244574-2013-00069
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 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

    THE INCORRECT REACTIVITY OF PRIMER MIX PMR014G WITH DRB1 11:09 AND LIKE ALLELES WAS A RESULT OF THE MIGRATION OF PRIMER MIX DATA SCORE, (THE LEGACY SOFTWARE PROGRAM USED IN DEVELOPMENT) THAT OCCURRED IN 2008. IN SCORE THE REACTIVITY WAS ASSIGNED AT THE PRIMER MIX LEVEL. THIS MEANS THE PATTERN WAS REJECTED AT THE MIX LEVEL AND NOT AT THE PRIMER LEVEL AS CURRENTLY IS DONE IN HOS. THE PATTERN CARRIES OVER TO THE NEXT MIX DESIGN AS IT IS DESIGNED TO DO IN HOS. DURING MIX DESIGN FOR PMR014G WHEN THE MIX WAS DUPLICATED IN HOS THE ASSIGNMENT WAS RETAINED CORRECTLY. THE PRIMERS USED IN THE MIX WERE CHANGED DURING DESIGN WITH PRIMER 3 'R209A2 (THE PRIMER RESPONSIBLE FOR DRB1 11:09) BEING REMOVED AT ONE POINT AND THEN PUT BACK INTO THE DESIGN. BECAUSE THE PATTERN WASN'T REJECTED AT THE PRIMER LEVEL FOR THIS PRIMER THE LINKAGE TO THE MIX PATTERN WAS BROKEN AND THUS REACTIVITY WAS INCORRECTLY ASSIGNED FOR THIS PRIMER MIX. THIS ISSUE PROMPTED RECALL 005-2013. A HEALTH HAZARD EVALUATION WAS PERFORMED, DMR0000544. CUSTOMER NOTIFICATIONS AND FIELD SAFETY NOTICES #'S ARE: DMR0000543 AND DMR0000542.

    Description of Event or Problem · 1

    IT WAS IDENTIFIED INTERNALLY DURING QUALITY CONTROL TESTING OF PRIMER MIX PMR014G THAT THE FOLLOWING ALLELES WERE INCORRECTLY LISTED AS POSITIVE LANES ON CUSTOMER KIT DOCUMENTATION: DRB1 11:09/87/113, DRB1 11:83, DRB1 13:05:01/05:02/06/42/136, DRB1 13:26:02, AND DRB1 13:56. THE LABORATORY CUSTOMER WOULD SEE A FALSE NEGATIVE ACCORDING TO THEIR DOCUMENTATION IN THE PRESENCE OF ANY OF THE ABOVE LISTED RARE ALLELES, THEREFORE, THERE MAY BE A DELAY IN PT TREATMENT DUE TO A POTENTIAL RETEST OR FURTHER ANALYSIS USING A DIFFERENT HLA TYPING METHOD. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573475 ABDRDQ SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORP. 029 1255127 1345427

    Patients

    Seq Age Sex Outcome Treatment
    1