BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CHEMISTRY TRIGLYCERIDE METHOD

    MDR report key: 1051308 · Received May 24, 2008

    Report

    Report Number
    2432235-2008-00060
    Event Type
    Other
    Date Received
    May 24, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 14, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUSSIONS WITH THE OEM REAGENT MANUFACTURER INDICATES THAT THE ADVIA CHEMISTRY TRIGLYCERIDE METHOD KIT LOT 095939 IS EXHIBITING LOWER THAN EXPECTED LINEARITY. THE ROOT CAUSE. INVESTIGATION IS UNDER WAY BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCORDANT TRIGLYCERIDE RESULT WHEN USING REAGENT LOT # 095939. THE SAMPLE INITIALLY READ 483 MG/DL AND UPON RETEST WITH A DILUTED SAMPLE, THE CORRECTED VALUE WAS 2120 MG/DL. THE CUSTOMER BECAME AWARE OF THIS PROBLEM WHEN SHE NOTICED THAT THE REACTION CURVE FOR THE INITIAL RESULT WAS DISCREPANT. THERE WAS NO PATIENT INTERVENTION AS A RESULT OF THIS DISCORDANT TRIGLYCERIDE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CHEMISTRY TRIGLYCERIDE METHOD TRIGLYCERIDE METHOD JGY SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA RGT. LOT # 095939

    Patients

    Seq Age Sex Outcome Treatment
    1