BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR/DQ 2T SSP UNITRAY KIT W/ TAQ

    MDR report key: 3558192 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00059
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    September 21, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE SEROLOGICAL TYPE ERROR WAS DUE TO A "BUG" FOUND IN THE HOS (HUMAN OLIGOTYPING SYSTEM) SOFTWARE WHICH ADDED A "1" INTO DQ7 AND DQ8 SEROLOGICAL TYPES. THE "BUG" IN THE SOFTWARE RESULTED IN A DISCREPANCY WITH SEROLOGICAL EQUIVALENTS IN THE HOS SOFTWARE RESULTED IN INCORRECT SEROLOGICAL EQUIVALENTS LISTED IN THE LABELING OF DR/DQ 2T SSP UNITRAY KIT WITH TAQ (CATALOG #7840110). THE INCORRECT LABELING MAY HAVE LED TO A DELAY IN PATIENT RESULT REPORTING. A MANUAL CORRECTION TO THE HOS SOFTWARE WAS MADE TO REMOVE "B1" FROM THE DQB18 TYPES. KIT DOCUMENTATION WAS UPDATED TO SHOW THE CORRECT SEROLOGICAL TYPES: DQ7 AND DQ8. CUSTOMER NOTIFICATIONS REGARDING THE CORRECTION WERE DISTRIBUTED AND KIT DOCUMENTATION WAS UPDATED TO REPLACE DQB17 AND DQB18 WITH DQ7 AND DQ8. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    (B)(6) FROM THE (B)(6) HLA LAB REPORTED THAT THE SEROLOGICAL EQUIVALENTS FOR THE DRDQ WERE NOT ASSIGNED CORRECTLY WHEN SHE USED DR/DQ 2T SSP UNITRAY KIT WITH TAQ (CATALOG #7840110, LOT #1103788). THE ALLELE STRINGS DQB1 03:01:01:01 HAD SEROLOGICAL EQUIVALENTS LISTED AS DQB17 AND DQB18 WHEN IT SHOULD HAVE BEEN DQ7 AND DQ8. DQB17 AND DQB18 DO NOT EXIST AS SEROLOGICAL TYPES. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528889 DR/DQ 2T SSP UNITRAY KIT W/ TAQ MZI LIFE TECHNOLOGIES CORP. 029 1103788

    Patients

    Seq Age Sex Outcome Treatment
    1