BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC TROP T

    MDR report key: 8647321 · Received May 28, 2019

    Report

    Report Number
    1823260-2019-01981
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 5, 2019
    Report Date
    June 24, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K964372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN: (B)(6). NO MATERIALS FROM THE CUSTOMER HAVE BEEN RETURNED FOR FURTHER INVESTIGATION. RELEVANT RETENTION LOT 32847610 WAS MEASURED ON QUALIFIED COBAS H232 WITH: THREE NEGATIVE BLOOD SAMPLES AND ONE SPIKED BLOOD SAMPLE (TARGET VALUE = 120 NG/L), IN COMPARISON TO THE MASTER LOT # 28237880. THE RESULTS FROM STRIP LOT 32847610: FIRST NEGATIVE BLOOD SAMPLE : <40 NG/L, SECOND NEGATIVE BLOOD SAMPLE: <40 NG/L, THIRD NEGATIVE BLOOD SAMPLE : <40 NG/L, SPIKED BLOOD SAMPLE: 116 NG/L. THE RESULTS FROM STRIP LOT 28237880: FIRST NEGATIVE BLOOD SAMPLE : <40 NG/L, SECOND NEGATIVE BLOOD SAMPLE: <40 NG/L, THIRD NEGATIVE BLOOD SAMPLE : <40 NG/L, SPIKED BLOOD SAMPLE: 124 NG/L. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ROCHE CARDIAC POC TROP T RESULTS FOR 1 PATIENT TESTED ON TWO COBAS H 232 METERS COMPARED TO A COBAS E 411 IMMUNOASSAY ANALYZER. THE SERIAL NUMBER FOR ONE H 232 METER WAS (B)(4). THE COBAS H232 IS NOT APPROVED FOR USE NOR IS A SIMILAR DEVICE APPROVED FOR USE IN THE UNITED STATES. THE RESULTS IN QUESTION FROM THE ROCHE CARDIAC POC TROP T WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "PECTORALGIA," CHEST PAIN. THE PATIENT HAD A CORONARY ANGIOGRAPHY BUT THERE WAS NO MYOCARDIAL INFARCTION DETECTED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. INTERNAL QUALITY CONTROL TESTING HAS BEEN PERFORMED ON BOTH COBAS H232'S WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438694 ROCHE CARDIAC TROP T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 32847611

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR