BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03801

    MDR report key: 4912892 · Received July 14, 2015

    Report

    Report Number
    1823260-2015-03801
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 14, 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). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TROPONIN T HS STAT RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.013 UG/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.539 UG/L WHICH WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 182603 WITH AN EXPIRATION DATE OF 04/29/2016. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA FOUND ALL WAS WITHIN SPECIFICATION. IT WAS NOTED THE SAMPLE WAS HEMOLYZED, THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE TUBE RACK ADAPTERS, AND THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION CONDITIONS. THESE FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE.

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR