BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH G7 ANALYZER CALIBRATOR

    MDR report key: 3421931 · Received September 25, 2013

    Report

    Report Number
    3005529799-2013-00013
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 25, 2013
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, (B)(4) WAS NOTIFIED BY A CUSTOMER THAT A G7 QC SHIFT HAD BEEN NOTED FOR THE HBA1C LEVEL 1 QC AFTER A PREVENTIVE MAINTENANCE HAD BEEN COMPLETED BY (B)(4) FIELD SERVICE ENGINEER. THE INVESTIGATION INDICATED THAT AN INCORRECT VALUE HAD BEEN ENTERED IN THE G7 ANALYZER FOR THE LEVEL 1 CALIBRATOR. AFTER THE PM WAS COMPLETED, PT SPECIMENS HAD BEEN RUN USING THE CALIBRATION WITH THE INCORRECT CALIBRATOR VALUE. ONCE THE ERROR WAS FOUND A NEW CALIBRATION WAS COMPLETED, PT SPECIMENS REPEATED, AND 15 CORRECTED REPORTS WERE ISSUED. NO PT TREATMENT WAS DONE BASED ON THE ERRONEOUS RESULTS. ROOT CAUSE: HUMAN ERROR. INCORRECT ENTRY OF CALIBRATOR 1 VALVE IN THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485723 TOSOH G7 ANALYZER CALIBRATOR G7 CALIBRATOR LCP TOSOH HI-TEC, INC. TOSOH G7 ZS2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other