BEUDAMED
    FDA Adverse Event Summary report: N

    DR/DQ 2T SSP UNITRAY W/TAQ 20 T

    MDR report key: 3528507 · Received December 12, 2013

    Report

    Report Number
    2244574-2013-00147
    Date Received
    December 12, 2013
    Date of Event
    October 29, 2013
    Report Date
    October 29, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK000019
    Removal / Correction Number
    RECALL 005-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF COMPLAINT #(B)(4) INDICATED THAT FOR PRODUCT DR/DQ 2T SSP UNITRAY 20 TESTS (CATALOG #7840110, LOT #030 1221267 1420379) LANE 15 MAY BE IMPACTED BY AN INCORRECT LABELING OF ALLELE REACTIVITY IF TESTED WITH ONE OR MORE OF 11 RARE DRB1 ALLELES: LANE 15 (PRIMER MIX PMR014G) PRODUCES A FALSE NEGATIVE IF TESTED WITH ANY OF DRB1*11:09, DRB1*11:87, DRB1*11:113, DRB1*11:83, DRB1*13:05:01, DRB1*13:26:02, DRB1*13:06, DRB1*13:42, DRB1*13:136, DRB1*13:26:02, AND DRB1*13:56 ALLELES. A NO TYPE OR MISTYPE RESULT COULD BE ENCOUNTERED IF A SAMPLE WITH ANY OF THE ABOVE ALLELE WERE TESTED WITH THE DESCRIBED PRODUCT AND LOT. THE INCORRECT REACTIVITY OF PMR014G WAS A RESULT OF THE MIGRATION OF PRIMER MIX DATA SCORE (LEGACY SOFTWARE PROGRAM) TO HOS (CURRENT SOFTWARE PLATFORM). IN SCORE REACTIVITY WAS ASSIGNED AT PRIMER MIX LEVEL, CAUSING THE PATTERN TO BE REJECTED AT MIX LEVEL AND NOT A PRIMER LEVEL AS IN HOS. THE PRIMERS USED IN THE MIX WERE CHANGED DURING DESIGN WITH PRIMER 3'R209A2 BEING REMOVED AT ONE POINT AND THEN PUT BACK. BECAUSE THE PATTERN WASN'T REJECTED AT PRIMER LEVEL, LINKAGE TO THE MIX PATTERN WAS BROKEN AND THUS REACTIVITY WAS INCORRECTLY ASSIGNED. ROOT CAUSE IS DETERMINED AS INCORRECT REACTIVITY PREDICTION FOR SCENARIOS DESCRIBED ABOVE AND A CORRECTION TO KIT DOCUMENTATION BEING MISSED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CUSTOMER COMPLAINT #(B)(4) THAT SAMPLES THAT ARE KNOWN TO BE DRB1:13:05 POSITIVE ARE PRODUCING A RESULT OF DRB1:13:04 WHEN USING ALLSET GOLD DRDQ SSP TRAYS (LOT 030 1272183). THE REACTION PATTERNS FOR THESE TWO ALLELES IS AS FOLLOWS: DRB1*13:05: 10, 11, 15, 26, DRB1*13:04: 10, 11, 26. THIS WOULD ALLEGE THAT LANE 15 IS PRODUCING A FALSE NEGATIVE RESULTS IN THE PRESENCE OF DRB1*13:05 SAMPLES AND THAT THIS IS LEADING TO A MISTYPE OF A DRB1*13:04. CATALOG #7840110, LOT #030 1221267 1420379 HAS BEEN IDENTIFIED AS A PRODUCT AFFECTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650980 DR/DQ 2T SSP UNITRAY W/TAQ 20 T MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP 030 1221267 1420379

    Patients

    Seq Age Sex Outcome Treatment
    1