BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04111

    MDR report key: 5065434 · Received September 9, 2015

    Report

    Report Number
    1823260-2015-04111
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 16, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 2 PATIENT SAMPLES. ONE PATIENT WAS TESTED FOR THYROTROPIN (TSH) AND ONE PATIENT WAS TESTED FOR TROPONIN T HS STAT (HIGH SENSITIVE SHORT TURN AROUND TIME) TROPONIN T HS STAT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL TSH RESULT WAS 0.041 UIU/ML. THE REPEAT RESULT WAS 0.742 UIU/ML. PATIENT 2 INITIAL TROPONIN T HS STAT RESULT WAS 20.90 PG/ML. THE SAMPLE WAS REPEATED 5 TIMES WITH RESULTS OF 4.38 PG/ML, 5.26 PG/ML, 3.36 PG/ML, 8.48 PG/ML, AND 8.43 PG/ML. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 184851 WITH AN EXPIRATION DATE OF 11/29/2015. THE TROPONIN T HS STAT REAGENT LOT NUMBER WAS 182603 WITH AN EXPIRATION DATE OF 04/29/2016. IT WAS NOTED THAT LIQUID FLOW CLEANING IS PERFORMED WEEKLY. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE CLEANED THE REAGENT PROBE AND SIPPER NOZZLE, CHECKED THE BEAD MIXER & WASHED THE MEASURING CELL.

    Patients

    Seq Age Sex Outcome Treatment
    1