BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST AIA-PACK TROPONIN 2ND GENERATION

    MDR report key: 2072593 · Received February 16, 2011

    Report

    Report Number
    3005529799-2011-00002
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    Manufacturer
    TOSOH AIA INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPORT (B)(4) DOCUMENTS THAT THE ST AIA-PACK TROPONIN 2ND GENERATION, LOT NUMBER A919369 WAS PERFORMING WITHIN SPECIFICATIONS. THE REPORTED ERRONEOUS RESULTS WERE NOT REPRODUCED, AND ALL PRECISION DATA HAD CVS OF <10% WHEN TESTING THE PRODUCT. NO ADDITIONAL ERRONEOUS RESULTS OR IMPRECISION HAVE BEEN REPORTED SINCE THE INITIAL OCCURRENCE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED (INCIDENT # (B)(4)) TO TOSOH BIOSCIENCE THAT TWO TROPONIN RESULTS ON SEPARATE PATIENTS WERE REPORTED AS ELEVATED. UPON A SECOND ROUND OF TESTING BOTH RESULTS WERE NORMAL. THE INITIAL SAMPLES WERE RETESTED, AND BOTH FELL BELOW THE CUT-OFF VALUE OF 0.06 NG/ML. QC RESULTS WERE WITHIN RANGE, AND NO OTHER PATIENT SAMPLES WERE DISCREPANT. TOSOH FIELD SERVICE WAS DISPATCHED TO INVESTIGATE THE REPORT AND DETERMINE IF THERE WERE INSTRUMENT ERRORS THAT COULD HAVE CAUSED THE DISCREPANCIES. THEY WERE UNABLE TO REPRODUCE THE REPORTED IMPRECISION, BUT MADE ADJUSTMENTS TO LIQUID MEASUREMENT VOLUMES FOR SAMPLE TUBE AND SAMPLE CUP. TEMPERATURES FOR SUBSTRATE, WASH AND THE INCUBATOR WERE ADJUSTED SLIGHTLY. THE DEVICE DID NOT FAIL TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED AS AN AID IN DIAGNOSIS. THE RESULTS THAT WERE REPORTED FROM THE USE OF THE DEVICE WERE ELEVATED WHICH CAUSED THE REPORT OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST AIA-PACK TROPONIN 2ND GENERATION TROPONIN MMI TOSOH AIA INC. A919369

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization