BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT PACK

    MDR report key: 934579 · Received April 12, 2007

    Report

    Report Number
    1319808-2007-00084
    Event Type
    Malfunction
    Date Received
    April 12, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 14, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT FOUND THAT THE REAGENT PACKS AND CALIBRATOR FLUIDS WERE FROZEN DUE TO A MALFUNCTIONING REFRIGERATOR. THE CUSTOMER OBTAINED FRESH REAGENTS AND FOLLOWING RECALIBRATION, QC RESULTS WERE ACCEPTABLE. THE ROOT CAUSE OF THE EVENT IS USER ERROR; THE CUSTOMER WAS NOT FOLLOWING OCD RECOMMENDED PROTOCOL FOR STORAGE CONDITIONS FOR THE VITROS REAGENT PACKS AND CALIBRATOR FLUIDS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NEGATIVELY BIASED VANC QC AND PATIENT RESULTS ON THE VITROS 5, 1 FS ANALYZER. ONE BIASED RESULT WAS REPORTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VANC REAGENT PACK IN VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS NA 1514-06-7094

    Patients

    Seq Age Sex Outcome Treatment
    1 *