BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-DIMER 25 TEST KIT

    MDR report key: 3884150 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00452
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GHH
    PMA / PMN Number
    K042890
    Removal / Correction Number
    FCA-008-14
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE LOT WAS RECALLED DUE TO POTENTIAL PERFORMANCE ISSUE. REFER TO (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTS RECEIVING THE E4 ERROR CODE ON TWO DIFFERENT PT SAMPLES. CUSTOMER THEN RAN L1 CONTOLS AND GOT AN INTERNAL QC ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296105 D-DIMER 25 TEST KIT CARDIAC MARKER TEST GHH ALERE SAN DIEGO, INC 98100 W53884B

    Patients

    Seq Age Sex Outcome Treatment
    1