BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1885525 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06444
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 19, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. A ROOT CAUSE COULD NOT BE IDENTIFIED. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN I RESULTS FOR THREE PATIENT SAMPLES. ALL RESULTS ARE IN NG/ML PATIENT SAMPLE 1 INITIAL RESULT WAS < 0.100 AND THE REPEAT RESULT WAS 0.142. ON (B)(6) 2010, PATIENT SAMPLE 2 FROM A (B)(6) MALE, THE INITIAL RESULT WAS < 0.100 AND THE REPEAT RESULT WAS 0.149. ON (B)(6) 2010, PATIENT SAMPLE 3 FROM A (B)(6) MALE, THE INITIAL RESULT WAS 0.117 AND THE REPEAT RESULT WAS 0.223 AND 0.220. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCIES. THE TROPONIN I REAGENT LOT NUMBER WAS 157789.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR