BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04327

    MDR report key: 5147072 · Received October 14, 2015

    Report

    Report Number
    1823260-2015-04327
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 27, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TROPONIN T HS RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.012 NG/ML. THE REPEAT RESULT WAS 0.017 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 182603 WITH AN EXPIRATION DATE OF 04/29/2016.

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR