BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRAY A LOCUS SSP

    MDR report key: 3427208 · Received September 26, 2013

    Report

    Report Number
    2244574-2013-00014
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 30, 2013
    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 A32:04 ALLELE IN PRIMER MIX PM019E WAS DETERMINED TO BE INCORRECT. PRODUCT LABELING WITH PRIMER MIX PM019E WILL BE UPDATED TO REMOVE SPECIFICITY FOR THE A 32:04 ALLELE. ADDITIONAL INVESTIGATION ACTIVITIES ARE STILL ONGOING AND WILL BE REPORTED IN THE 30-DAY REPORT. AFFECTED LOTS OF UNITRAY A LOCUS SSP KITS (CATALOG # 7860010). LOT: 022 1256848, MFG. DATE: 11/2012, EXP. DATE: 07/2014 - MFR 2244574-2013-00073.

    Description of Event or Problem · 1

    THIS EVENT WAS A RESULT OF THE INTERNAL COMPLAINT INVESTIGATION FOR PROBLEM REPORT PR #1(B)(4). THE REACTIVITY ASSIGNMENT IN OUR HUMAN OLIGOTYPING SOFTWARE (HOS) PROGRAM FOR A32:04 ALLELE IN PRIMER MIX PM019E WAS DETERMINED TO BE INCORRECT. UNITRAY A LOCUS SSP KITS (CATALOG # 7860010, LOT # 022 1221256 AND LOT # 022 1256848) WERE AFFECTED BY THE INCORRECT A32:04 ALLELE ASSIGNMENT. THE KITS WILL PRODUCE AN INCORRECT LOW RESOLUTION TYPING OR MISTYPING RESULT OF A 02, A 03 ALLELES WHEN TESTING A SAMPLE WHICH HAS THE A 32:04 ALLELE. 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. THERE HAVE BEEN NO EXTERNAL COMPLAINTS REGARDING UNITRAY A LOCUS SSP KITS (CATALOG # 7860010, LOT # 022 1221256 AND LOT # 022 1256848).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488345 UNITRAY A LOCUS SSP MZI 022 1221256

    Patients

    Seq Age Sex Outcome Treatment
    1