BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03781

    MDR report key: 4905361 · Received July 10, 2015

    Report

    Report Number
    1823260-2015-03781
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    July 10, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 QUESTIONED RESULTS FOR 2 PATIENTS TESTED FOR TROPONIN T HS STAT (HIGH SENSITIVE SHORT TURN AROUND TIME) TROPONIN T HS STAT. OF THE DATA PROVIDED, THE RESULTS FROM 1 PATIENT WERE ERRONEOUS. IT IS UNCLEAR IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS STAT RESULT WAS <3.00 PG/ML WITH A DATA FLAG. ON (B)(6) 2015 THE SAMPLE WAS REPEATED WITH RESULTS OF <3.00 PG/ML WITH A DATA FLAG AND 3.51 PG/ML. A RESULT OF 3.71 PG/ML WAS ALSO PROVIDED, HOWEVER, IT IS UNCLEAR IF THIS RESULT WAS A TYPOGRAPHICAL ERROR OF THE 3.51 PG/ML RESULT OR WAS AN ADDITIONAL REPEAT RESULT. THE RESULTS OF <3.00 PG/ML WERE CONSIDERED TO BE CORRECT. IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENT WAS REPORTED. THE TROPONIN T HS STAT REAGENT LOT NUMBER WAS 182603 WITH AN EXPIRATION DATE OF 04/30/2016. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. MAINTENANCE LOGS WERE CHECKED AND IT WAS NOTED THAT PINCH TUBING HAD BEEN REPLACED. LIQUID FLOW CLEANING WAS PERFORMED ON (B)(6) 2015. IT WAS NOTED THAT WHEN THE CUSTOMER CHECKED THE ONBOARD REAGENTS, CRYSTALS WERE IDENTIFIED ON THE REAGENT PROBES OF TNT AND HCG REAGENTS. A FIELD SERVICE ENGINEER VISIT WAS REQUESTED TO CHANGE MEASURING CELLS AND RUN SYSTEM CHECKS ON THE ANALYZER. THE FIELD SERVICE ENGINEER FOUND THAT THE ANALYZER WAS PLUGGED ONTO A MULTI-PLUG DEVICE ALONG WITH OTHER INSTRUMENTS. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. POSSIBLE ROOT CAUSES FOR THE ERRONEOUS RESULTS MAY BE RELATED TO THE ANALYZER BEING PLUGGED INTO ONE CIRCUIT WITH OTHER INSTRUMENTS OR A WORN PINCH TUBE.

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR