BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC T QUANTITATIVE

    MDR report key: 2780883 · Received October 10, 2012

    Report

    Report Number
    1823260-2012-05060
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    February 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K964372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE INSTRUMENT DID NOT MALFUNCTION AND WORKED WITHIN THE SPECIFIED LIMITS. NO ERROR MESSAGES WERE RECORDED ON THE COBAS H 232 AND ALL CONTROLS WERE ACCEPTABLE. THE COBAS H232 SERIAL NUMBER (B)(4) WAS SUBMITTED FOR FURTHER INVESTIGATION AND TESTED WITH RELEVANT RETENTION MATERIAL. THE RESULTS OF THE TESTING WERE WITHIN SPECIFICATIONS. FURTHER TESTING DID NOT REPRODUCE THE ERROR AND WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CARDIAC TROPONIN T RESULTS FOR ONE PATIENT. THE INITIAL RESULT FROM COBAS H 232 METER SERIAL NUMBER (B)(4) IN THE ACUTE REFERRAL UNIT (ARU) WAS 234 NG/L. THE PATIENT WAS DIAGNOSED WITH AN MI AND ADMITTED TO CORONARY INTENSIVE CARE UNIT (ICU) BASED ON THIS COBAS H 232 TROPONIN T RESULT. SUBSEQUENT BLOOD SAMPLES WERE TAKEN AND SENT TO THE MAIN LABORATORY FOR CONFIRMATION. THE TROPONIN T RESULT FROM AN ELECSYS E170 ANALYZER WAS <29 NG/L. THE TROPONIN T TESTING WAS REPEATED ON THE COBAS H 232 IN THE ARU WITH A RESULT OF 178 NG/L AND IN THE ICU WITH A RESULT OF 147 NG/L. ON (B)(6) 2012, A SERUM SAMPLE FROM THE PATIENT WAS SENT TO THE CORE LAB FOR ANALYSIS ON AN INDEPENDENT COBAS H 232 METER SERIAL NUMBER (B)(4) AND CARDIAC TROPONIN T STRIP LOT 28092310 EXPIRING ON 08/2013. THE RESULT FROM THE SAMPLE ON THE COBAS H232 METER WAS 50-100 NG/L. THE SAME SAMPLE WAS TESTED ON AN ELECSYS E170 AND THE RESULT WAS 7.960 NG/L. THE PATIENT DID NOT UNDERGO ANY PROCEDURES OR TREATMENT BASED ON THE RESULTS AND IS NOW DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE CARDIAC T QUANTITATIVE TROPONIN T QUANTITATIVE MMI ROCHE DIAGNOSTICS NA 28087310

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR