BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT

    MDR report key: 2312003 · Received October 27, 2011

    Report

    Report Number
    2050012-2011-06540
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    October 2, 2011
    Report Date
    October 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LCP
    PMA / PMN Number
    K042459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT WERE ALSO SUBMITTED UNDER REPORT NUMBERS 2050012-2011-06538 AND 2050012-2011-06539. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).) REPLACEMENT REAGENT RESOLVED ISSUE.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 600 SYNCHRON SYSTEM GENERATED MULTIPLE FALSELY LOW RESULTS WHEN USING HEMOGLOBIN A1C2 (HBA1C2) REAGENT LOT M102325 ON (B)(6) 2011, (B)(6) 2011, AND (B)(6) 2011. THIS IS THE THIRD OF THREE REPORTS SUBMITTED FOR THIS EVENT COMPLAINT. THE CUSTOMER TECHNICAL SPECIALIST SENT REPLACEMENT (HBA1C2) REAGENT, LOT M104106, AND CUSTOMER STATED THAT THE RESULT RECOVERY FROM THIS LOT WAS HIGHER. CUSTOMER STATED THAT ALTHOUGH RESULTS WERE REPORTED OUTSIDE THE LABORATORY, THEY WERE AMENDED AFTER USE OF THE REPLACEMENT LOT AND DID NOT AFFECT PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT ASSAY, GLYCOSYLATED HEMOGLOBIN LCP BECKMAN COULTER, INC. HBA1C2 REAGENT M102325

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR