BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY KIT

    MDR report key: 3409520 · Received September 24, 2013

    Report

    Report Number
    2244574-2013-00008
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Report Date
    May 13, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 09/23/2013 INTERNAL INVESTIGATION FOR (B)(4) IS ON-GOING. REF MFR: 2244574-2013-00077, -00078, -00080, -00084.

    Description of Event or Problem · 1

    EXTERNAL CUSTOMER COMPLAINT (B)(4). (B)(6) REPORTED A DISCREPANCY BETWEEN HIS DPB1 UNITRAY SSP (MODEL #451606D, LOT #008 1154360) RESULTS AND SBT TYPING ON A SAMPLE. THE SAMPLE TYPED AS A DPB1 03:01:01/88:01 BY SEQUENCING. DPB1 HIGH RESOLUTION SSP TRAY DID NOT GIVE A RESULT. CUSTOMER INDICATED THAT WELLS 27 AND 39 WERE FALSE NEGATIVE. THIS LED TO A NO TYPE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483114 DPB1 SSP UNITRAY KIT MZI LIFE TECHNOLOGIES CORP 008 1154360

    Patients

    Seq Age Sex Outcome Treatment
    1