BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE BNP TEST FOR BECKMAN COULTER

    MDR report key: 3943573 · Received April 30, 2014

    Report

    Report Number
    2027969-2014-00391
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K052789
    Removal / Correction Number
    2027969-03/20/14-002C
    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 BCI BNP CONTROLS OUT OF RANGE HIGH WITH MICROGENICS CORP CONTROLS L1-3. CUSTOMER USING MICROGENICS CORP CONTROLS - FOR BNP AND CK-MB. ACCOUNT HAS BEEN USING CONTROLS FROM THE SAME COMPANY WITHOUT ANY PREVIOUS ISSUES. CUSTOMER STATES THAT L3 WAS HIGH BUT WITHIN RANGE, HOWEVER, ALSO BECAME OUT OF RANGE AFTER RE-CALIBRATING INSTRUMENT AND RE-RUNNING CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258593 TRIAGE BNP TEST FOR BECKMAN COULTER B-TYPE NATRIURETIC PEPTIDE TEST NBC ALERE SAN DIEGO, INC. 98200 329599

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROGENICS CORP CONTROLS FOR BNP AND CK-MB