BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC TEST STRIP TROPONIN T

    MDR report key: 3033342 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02021
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 9, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K000784
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. STANDARD TESTS WERE PERFORMED. ALL THE RESULTS FULFILLED THE REQUIREMENTS. THE OPTICS WERE CHECKED. NO ERRORS WERE FOUND. ALL PRODUCT CLAIMS WERE MET.

    Additional Manufacturer Narrative · 1

    TWO INDIVIDUAL TEST STRIPS FORM LOT NUMBER 28116810 WERE RETURNED FOR INVESTIGATION, HOWEVER THEY WERE NOT SHIPPED ACCORDING TO THE TEMPERATURE REQUIREMENTS. THE CUSTOMER ALSO RETURNED AN H232 WITH SERIAL NUMBER (B)(4). SAMPLES WERE TESTED ON THE RETURNED H232, A RETENTION H232 ANALYZER AND AN ELECSYS 2010. THE RESULTS FROM THE RETURNED H232 WERE LOWER THAN THE RETENTION H232. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE CARDIAC TROPONIN T (TNT) RESULT ON THEIR COBAS H232 ANALYZER, SERIAL NUMBER (B)(4). THE TNT STRIP EXPIRATION DATE PROVIDED WAS 01/2014. THE PATIENT'S INITIAL TNT RESULT WAS 204 NG/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS TESTED ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4), USING THE TROPONIN T HIGH SENSITIVE REAGENT (TNTHS), WHICH IS NOT SOLD IN THE UNITED STATES. THE TNTHS RESULT WAS 27.9 NG/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. IT WAS NOT CLEAR IF THE RESULTS CAME FROM THE SAME SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. AN INVESTIGATION WAS PERFORMED ON RETENTION TNT STRIP USING LOT NUMBER 28116810 ON AN H232 ANALYZER. THE RESULTS OF ALL THE MEASUREMENTS FULFILLED THE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136802 ROCHE CARDIAC TEST STRIP TROPONIN T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 28116810

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR