BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AB/DR SSP UNITRAY W/TAQ 10 TS

    MDR report key: 3622620 · Received December 12, 2013

    Report

    Report Number
    2244574-2013-00134
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    October 29, 2013
    Report Date
    October 29, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    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 #7840010, LOT #031 1344994) 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 13:05:02, 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 AT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN INTERNAL COMPLAINT #(B)(4) THAT PRIMER MIX PMR014G HAS A DRB1 11:09 ALLELE LISTED AS A NEGATIVE LANE ON THE TESTING SHEET. IN HOS THIS ALLELE IS IDENTIFIED AS AN "?" ALLELE. ACCORDING TO THIS, THE CUSTOMER DOCUMENTATION WOULD IDENTIFY THIS ALLELE AS A POSITIVE ALLELE. IN TESTING THE RESULT SHOWS THAT DRB1 11:09 PRODUCES A NEGATIVE RESULT. THEREFORE, THE CUSTOMER WOULD SEE A FALSE NEGATIVE FOR SEVERAL SPECIFIC ALLELE TYPES ACCORDING TO THE DOCUMENTATION. CATALOG #78400100, LOT #031 1344994 HAS BEEN IDENTIFIED AS A PRODUCT AFFECTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651564 AB/DR SSP UNITRAY W/TAQ 10 TS MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 031 1344994

    Patients

    Seq Age Sex Outcome Treatment
    1