BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST AIA-PACK 27.29

    MDR report key: 2536348 · Received April 9, 2012

    Report

    Report Number
    3005529799-2012-00005
    Event Type
    Injury
    Date Received
    April 9, 2012
    Report Date
    April 2, 2012
    Manufacturer
    TOSOH AIA, INC.
    Product Code
    CKG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ACCOUNT CALLED TOSOH BIOSCIENCE, INC. TECHNICAL SUPPORT AND REPORTED THAT ONE 27.29 RESULT HAD INITIALLY BEEN REPORTED AS 30 U/ML WITH NO INSTRUMENT FLAGS. ACCOUNT HAS AUTO RELEASE FUNCTION AND THE RESULT WAS REPORTED. THE PHYSICIAN QUESTIONED THE RESULT AND THE SPECIMEN WAS PULLED TO BE REPEATED AT WHICH TIME IT WAS NOTED THAT THERE WAS A CLOT IN THE SPECIMEN. THE CLOT WAS REMOVED AND THE SPECIMEN WAS RE-CENTRIFUGED. THE SPECIMEN WAS REPEATED AND THE 27.29 RESULT WAS 238 U/ML. THE PATIENT'S PREVIOUS 27.29 RESULTS WERE USUALLY AROUND 300 U/ML. THE PATIENT IS AN OUTPATIENT. ACCOUNT STATED THAT THE LABORATORY TECHNICIAN HAD NOT VISUALLY CHECKED THE SPECIMEN FOR CLOTS PRIOR TO THE INITIAL ANALYSIS. ROOT CAUSE OF THE ERRONEOUS RESULT IS THE PRESENCE OF A CLOT IN THE SPECIMEN THAT WAS NOT REMOVED PRIOR TO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST AIA-PACK 27.29 27.29 CKG TOSOH AIA, INC. NA TEST CUPS B819113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other