BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH G8 AUTOMATED HPLC (OPERATOR ERROR)

    MDR report key: 4941856 · Received July 23, 2015

    Report

    Report Number
    3005529799-2014-00009
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 22, 2015
    Manufacturer
    TOSOH HI-TEC, INC.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 TOSOH BIOSCIENCE, INC. WAS NOTIFIED OF ERRONEOUS RESULTS THAT HAD BEEN RELEASED ON (B)(6) 2015. THE TESTING WAS DONE ON A TOSOH HPLC G8 ANALYZER. ALL QCS WERE WITHIN ACCEPTABLE TARGET RANGES. THE COLUMN COUNT WAS 3800 AND THE LAST CALIBRATION HAD BEEN DONE ON (B)(6) 2015. PT SAMPLES WERE TESTED AND REPORTED TO THE PHYSICIAN. CHROMATOGRAMS WERE REVIEWED AFTER THE RESULTS WERE REPORTED AND IT WAS DISCOVERED THAT THE CHROMATOGRAM PEAKS LOOKED ABNORMAL AND RESULTS SHOULD NOT HAVE BEEN REPORTED. A NEW COLUMN WAS INSTALLED, CALIBRATED AND QC RUN. THE QC WAS ACCEPTABLE AND THE CHROMATOGRAM PEAKS LOOKED NORMAL. APPROXIMATELY 200 PT RESULTS FOR THE DAY WERE REVIEWED AND ANY PT RESULT THAT HAD RESULTS IN THE RANGE 7.0 TO 7.9 (43 SPECIMENS) WERE REPEATED ON THE NEW COLUMN. RESULTS WERE LOWER ON THE REPEATED RESULTS AND CORRECTED RESULTS WERE REPORTED. ROOT CAUSE: OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480491 TOSOH G8 AUTOMATED HPLC (OPERATOR ERROR) G8 LPC TOSOH HI-TEC, INC. G8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other