BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON HEMOGLOBIN A1C2 REAGENT

    MDR report key: 1951764 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00076
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LCP
    PMA / PMN Number
    K042459
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CUSTOMER RECEIVED A LEAKING HEMOGLOBIN A1C2 (%HBA1C2) REAGENT. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON HEMOGLOBIN A1C2 REAGENT HEMOGLOBIN A1C2 REAGENT LCP BECKMAN COULTER INC. N/A M006399

    Patients

    Seq Age Sex Outcome Treatment
    1