BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE BNP TEST FOR BECKMAN COULTER

    MDR report key: 3884173 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00447
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K052789
    Removal / Correction Number
    202796-03/20/14-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    LOW RECOVERY ON BNP BCIS FOR L1 AND L3 BIO-RED CONTROLS FOR 1 LOT OF REAGENT; CUSTOMER COULD NOT PROVIDE VALUES. OCCURRING ON LOT 331265. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295460 TRIAGE BNP TEST FOR BECKMAN COULTER B-TYPE NATRIURETIC PEPTIDE TEST NBC ALERE SAN DIEGO, INC 98200 331265

    Patients

    Seq Age Sex Outcome Treatment
    1 BIO-RAD CONTROLS