BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSOH ST AIA-PACK BHCG

    MDR report key: 3069378 · Received April 16, 2013

    Report

    Report Number
    3005529799-2013-00005
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    TOSOH AIA, INC., 2
    Product Code
    JHI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), AS PART OF THE INVESTIGATION, A PRECISION STUDY (N=15), WAS ALSO PERFORMED ON THE PATIENT SAMPLE, AND THE RESULTS WERE; 47, 46, 44, 46, 47, 46, 47, 47, 45, 46, 45, 48, 47, 47, 48. ON (B)(6), A CORRECTED REPORT WAS THEN SENT TO THE PATIENT WITH A FINAL RESULT OF 44 MIU/ML. IT WAS CONFIRMED THAT THE PATIENT WAS NOT TREATED BASED ON THE INITIAL REPORT AND THERE WAS NO HARM TO THE PATIENT. ON (B)(6) 2013, THE PATIENT WAS ALSO INFORMED OF THE CORRECTED RESULT. ROOT CAUSE: NOT CONFIRMED BUT SINCE THIS ONLY OCCURRED ON ONE SPECIMEN IT IS SUSPECTED THAT IT WAS A SPECIMEN ISSUE, POSSIBLY A FIBRIN CLOT THAT PREVENTED ACCURATE ANALYSIS ON THE INITIAL RUN.

    Description of Event or Problem · 1

    ON (B)(4) 2013, TOSOH BIOSCIENCE, INC. WAS NOTIFIED BY A CUSTOMER LABORATORY THAT ON (B)(6)2013 AN ERRONEOUS BHCG PATIENT RESULT WAS REPORTED AS <L (<5.0 MIU/ML). THIS RESULT WAS NOT QUESTIONED BY THE PHYSICIAN AND THE LAB INDICATED THAT ALL QC WERE WITHIN EXPECTED RANGES. THE PATIENT SAMPLE WAS THE FIRST ONE RUN AFTER QUALITY CONTROL AND THE LABORATORY PROTOCOL IS TO REPEAT ALL FIRST RUN PATIENT SAMPLES OF THE DAY AS A "CONTROL" AT THE END OF THAT SAME DAY. THIS WAS DONE AND THE BHCG RESULT WAS 441 MIU/ML. DUE TO THE DISCREPANCY IN VALUES IT WAS REPEATED AND THE RESULT WAS 46 MIU/ML. THE PATIENT SAMPLE WAS EXAMINED FOR THE PRESENCE OF FIBRIN AND NONE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162929 TOSOH ST AIA-PACK BHCG BHCG JHI TOSOH AIA, INC., 2 NA CY171A5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other