BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, TRIAGE, CARDIAC TNI

    MDR report key: 4278542 · Received November 18, 2014

    Report

    Report Number
    2027969-2014-01019
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGING DISCREPANT LOW TNI WHEN WB PATIENT SAMPLE WAS RUN ON METER (B)(4) AT <0.05 - POS ON SIEMENS AT 0.510; POS ON METER (B)(4) AT 0.13 (TRIAGE TNI CUTOFF OF 0.05). CUSTOMER ALLEGING THERE WAS A METER THAT WASN'T WORKING. SHE HAD NO DETAILS BUT THERE WAS A PATIENT SAMPLE RUN ON ONE METER AND WAS NEG FOR TNI. SAME SAMPLE RUN ON OTHER METER WAS POS. ALTERNATE METHOD SHOWED TNI AT "30X THE AMOUNT." CUSTOMER MENTIONED CONTROLS RAN LOWER ON THAT ONE METER. NO DETAILS PROVIDED. QCD PASSED. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745646 KIT, TRIAGE, CARDIAC TNI CARDIAC MARKET TEST GJS ALERE SAN DIEGO, INC. 97021HS W58300RB

    Patients

    Seq Age Sex Outcome Treatment
    1