BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC T QUANT 10 TESTS (COBAS)

    MDR report key: 2992135 · Received March 7, 2013

    Report

    Report Number
    1823260-2013-01370
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K964372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE H232 ANALYZER AND ONE PACKAGE OF CARDIAC T TEST STRIPS, LOT NUMBER 28086015, CONTAINING FOUR UNUSED STRIPS FOR INVESTIGATION. THE RESULTS OF ALL THE TESTING MET THE REQUIREMENTS. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CARDIAC T QUANT RESULTS FOR ONE PATIENT ON THEIR COBAS H 232 ANALYZER, SERIAL NUMBER (B)(4). THE PATIENT WAS BORN IN (B)(6) 1975. THE PATIENT'S INITIAL CARDIAC T RESULT WAS 50-100 NG/L, BUT THEY COULD NOT VISUALLY SEE A LINE ON THE TEST STRIP. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS 50-100 NG/L, BUT AGAIN THEY COULD NOT VISUALLY SEE A LINE ON THE TEST STRIP. THE RESULT OF 50-100 NG/L WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHEN AN EKG, SATURATION AND BLOOD SAMPLES WERE TAKEN. THE PATIENT HAD A TROPONIN T HIGH SENSITIVE TEST PERFORMED, AND THE RESULT WAS <5 NG/L. AFTER THIS, THE PATIENT WAS SENT HOME WITH AN ORDER TO CONTACT THE HOSPITAL IF HEART PAINS RE-OCCURRED. THE PATIENT WAS NOT HARMED BY THIS EVENT. THE H232 DEVICE WAS REPLACED INTERNALLY AND NO LONGER IN USE. RETENTION TEST STRIPS, LOT NUMBER 28086010, WERE TESTED ON AN H232 DEVICE. THE RESULTS OF ALL THE TESTS FULFILLED THE REQUIREMENTS, AND THE TEST STRIPS DID NOT SHOW ANY ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97194 ROCHE CARDIAC T QUANT 10 TESTS (COBAS) IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 28086015

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR