BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1760185 · Received July 16, 2010

    Report

    Report Number
    1823260-2010-04196
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 16, 2010
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TROPONIN T RESULT FOR ONE PATIENT SAMPLE ON THE ANALYTICAL E MODULE ANALYZER. THE USER STATED WHEN THE PATIENT ARRIVED AT THE FACILITY, A SAMPLE WAS DRAWN AND THE TROPONIN T RESULT WAS ELEVATED. SHE COULD NOT PROVIDE THE EXACT RESULT. LATER, ANOTHER SAMPLE WAS DRAWN WHICH GAVE A RESULT OF 0.01 NG/ML. THIS RESULT WAS REPORTED TO THE NURSE IN THE ER WHO QUESTIONED THE RESULT AND REQUESTED THE SAMPLE BE REPEATED. THE USER STATED IT WAS NOT CLEAR IF THE NURSE WAS AWARE OF THE ELEVATED TROPONIN T RESULT FROM THE INITIAL SAMPLE OR IF HER QUESTION WAS BASED ON AN EKG RESULT. THE SAMPLE WAS POURED OFF INTO A SAMPLE CUP AND TESTED. THE REPEAT RESULT WAS 0.34 NG/ML. THE USER CALLED THE ER WITH THE CORRECTION. THE USER DECLINED TO PROVIDE ANY INFORMATION REGARDING POSSIBLE ADVERSE EFFECTS TO THE PATIENT RELATED TO THIS EVENT. THE TROPONIN T REAGENT LOT NUMBER WAS 15789501. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE RAN PERFORMANCE CHECKS AND PRECISION TESTING WITH PERFECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER MMI NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1