BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECORE GSSP PRIMER SET

    MDR report key: 3558217 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00046
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    December 28, 2011
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION FOR SECORE GSSP PRIMER SET (CATALOG # A10918) LOT 1022071 (SOURCE BULK (B)(4)) WERE CONFIRMED PRODUCT MALFUNCTIONS. ROOT CAUSE IS NOT DETERMINED. PROBABLE ROOT CAUSE IS PRIMER SYNTHESIS ERROR. PRODUCT A10918 LOT 1029313 (SOURCE BULK (B)(4)) WERE NOT CONFIRMED AND CONTINUED TO PERFORM TO SPECIFICATION. THIS PRODUCT DOES NOT HAVE A 510 (K) IT IS SELF DECLARED IN THE EU UNDER (B)(4). LOT 1022071 (SOURCE BULK LOT (B)(4)). MFG DATE 07/01/2011. EXPIRATION DATE: 01/01/2014. THIS IS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER AT THE (B)(6) LAB EXPERIENCED PRODUCT PERFORMANCE ISSUES (HIGH BACKGROUND, LOW SIGNAL) WITH A10918 LOT 1022071 AND A10918 LOT 1029313 WHEN USING SECORE GSSP PRIMER SET (CATALOG # A10918). GSSP PRIMER SYNTHESIS ERRORS RESULT IN A NO TYPE RESULT. CUSTOMER COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529189 SECORE GSSP PRIMER SET MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP 1029313

    Patients

    Seq Age Sex Outcome Treatment
    1