BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04450

    MDR report key: 5204923 · Received November 5, 2015

    Report

    Report Number
    1823260-2015-04450
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 16, 2015
    Report Date
    December 1, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A SAMPLE HANDLING ISSUE CANNOT BE EXCLUDED AS THE CENTRIFUGATION TIME WAS VERY SHORT (3 MINUTES).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4)

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE ALARM TRACE, THERE IS NO INDICATION OF AN INSTRUMENT ISSUE. THE ANALYZER PERFORMANCE CHECK ON (B)(6) 2015 WAS ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR TROPONIN T HS STAT (HIGH SENSITIVE SHORT TURN AROUND TIME) TROPONIN T HS STAT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS STAT RESULT WAS 169.2 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THIS RESULT WAS BELIEVED TO BE TOO HIGH. A SECOND SAMPLE WAS OBTAINED AND THE RESULT WAS 3.00 PG/ML WITH A DATA FLAG. A THIRD SAMPLE WAS OBTAINED AND THE RESULT WAS 3.00 PG/ML WITH A DATA FLAG. THE INITIAL SAMPLE WAS REPEATED AND THE RESULT WAS 3.00 PG/ML WITH A DATA FLAG. NO ADVERSE EVENT WAS REPORTED. THE TROPONIN T HS STAT REAGENT LOT WAS 182603. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. IT WAS NOTED THAT THE CENTRIFUGATION TIME WAS 3 MINUTES. THIS IS A VERY SHORT TIME AS THE RECOMMENDED CENTRIFUGATION TIME DEPENDING ON TUBE MANUFACTURERS IS BETWEEN 10-15 MINUTES. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE DATA PROVIDED, A SAMPLE HANDLING ISSUE CANNOT BE EXCLUDED.

    Patients

    Seq Age Sex Outcome Treatment
    1