BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIANT II TURBO SYSTEM W/CDM VER. 4.0

    MDR report key: 1203149 · Received October 17, 2008

    Report

    Report Number
    2915274-2008-00002
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    LCP
    PMA / PMN Number
    K063400
    Removal / Correction Number
    2915274-10/17/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED CUSTOMER'S VARIANT II TURBO INSTRUMENT AND COMPUTER WITH CDM VERSION (B) (4) ON 10/14/2008. CURRENTLY THE SYSTEM IS UNDER INVESTIGATION FOR ROOT CAUSE DETERMINATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SINGLE CASE IN WHICH A BARCODE ID AND TUBE POSITION NUMBER WERE ASSIGNED TO BOTH THE CORRECT SAMPLE RESULT AND TO THE NEXT SAMPLE RESULT. SUBSEQUENT SAMPLE RESULTS IN THAT RUN WERE ASSIGNED THE BARCODE NUMBER AND TUBE POSITION NUMBER OF THE PRIOR TUBE. TWENTY ONE PATIENT RESULTS WERE REPORTED OUT THAT SUBSEQUENTLY THE LABORATORY CORRECTED WITH THE PHYSICIAN. THE CUSTOMER DID NOT REPORT DEATH OR SERIOUS INJURY IN THIS INCIDENCE. THE VARIANT II TRUBO INSTRUMENT WITH CDM VERSION (B) (4) SOFTWARE IS AN AUTOMATED HPLC SYSTEM THAT SEPARATES AND REPORTS PERCENT HEMOGLOBIN A1C IN EDTA WHOLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIANT II TURBO SYSTEM W/CDM VER. 4.0 GLYCOSYLATED HEMOGLOBIN ASSAY LCP BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1