BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AB/DR SSP UNITRAY W/TAQ

    MDR report key: 3435249 · Received October 2, 2013

    Report

    Report Number
    2244574-2013-00022
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 30, 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 INTERNAL INVESTIGATION IDENTIFIED THAT THE REACTIVITY ASSIGNMENT IN OUR HUMAN OLIGOTYPING SOFTWARE (HOS) PROGRAM FOR (B)(4) IN PRIMER (B)(4) WAS DETERMINED TO BE INCORRECT. PRODUCT LABELING WITH PRIMER (B)(4) WILL BE UPDATED TO REMOVE SPECIFICITY FOR THE (B)(4). ADDITIONAL INVESTIGATION ACTIVITIES ARE STILL ONGOING AND WILL BE REPORTED IN THE 30-DAY REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS A RESULT OF THE INTERNAL COMPLAINT INVESTIGATION FOR PROBLEM REPORT (B)(4). THE REACTIVITY ASSIGNMENT IN OUR HUMAN OLIGOTYPING SOFTWARE (HOS) PROGRAM FOR (B)(4) IN PRIMER (B)(4) WAS DETERMINED TO BE INCORRECT. AB/DR SSP UNITRAY W/TAQ (CATALOG# 7810110, LOT# 036 1316325 1409712) WAS AFFECTED BY THE INCORRECT (B)(4) ASSIGNMENT. THE KITS WILL PRODUCE AN INCORRECT LOW RESOLUTION TYPING OR MISTYPING RESULT OF (B)(4) WHEN TESTING A SAMPLE WHICH HAS THE A (B)(4). THE USER WILL BE UNAWARE OF THE INCORRECT TYPE, UNLESS THEY CONFIRM THE SAMPLE TYPING BY ANOTHER METHOD, THEREFORE, THIS WOULD BE CONSIDERED A MISTYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498757 AB/DR SSP UNITRAY W/TAQ MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP. 036 1316325 1409712

    Patients

    Seq Age Sex Outcome Treatment
    1