BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSOH AIA-PACK ST INTACT PTH

    MDR report key: 2612782 · Received May 15, 2012

    Report

    Report Number
    3005529799-2012-00006
    Event Type
    Other
    Date Received
    May 15, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 15, 2012
    Manufacturer
    TOSOH AIA, INC.
    Product Code
    JJY
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TOSOH BIOSCIENCE ANALYTE APPLICATION MANUAL FOR INTACT PTH STATES THAT "SERUM, EDTA PLASMA IS REQUIRED FOR THE ASSAY. HEPARINIZED OR CITRATED PLASMA SHOULD NOT BE USED." THE CUSTOMER CALLED TO ASK WHY HEPARINIZED PLASMA COULD NOT BE USED AND INDICATED THAT AN INTACT PTH RESULT HAD BEEN REPORTED ON A HEPARINIZED PLASMA SPECIMEN. THE CUSTOMER WAS ADVISED TO OBTAIN THE CORRECT SPECIMEN TYPE FOR TESTING AND TO INFORM THE PHYSICIAN OF THE ERRONEOUS RESULTS. THE PHYSICIAN WAS NOTIFIED, BUT HIS RESPONSE WAS THAT THE HEPARINIZED PLASMA RESULTS WERE ACCEPTABLE SINCE HE WANTED TO COMPARE BEFORE SURGERY AND AFTER SURGERY RESULTS FOR A DROP IN THE VALUES AND THE ACTUAL VALUES WERE NOT CRITICAL. THERE WAS NO ADVERSE EVENT RESULTING FROM AN INCORRECT SPECIMEN TYPE BEING USED TO REPORT INTACT PTH RESULTS. ROOT CAUSE: HUMAN ERROR. ANALYZER OPERATOR USED INCORRECT SPECIMEN TYPE FOR THE INTACT PTH TESTING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN LOT NUMBERS, BUT THESE WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSOH AIA-PACK ST INTACT PTH INTACT PTH JJY TOSOH AIA, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other