BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC TROP T

    MDR report key: 7163586 · Received January 4, 2018

    Report

    Report Number
    1823260-2018-00063
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 18, 2017
    Report Date
    February 16, 2018
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE SECOND SAMPLE TESTED WITH THE LABORATORY METHOD RESULTED AS 76 NG/L AT 20:10. THE 76 NG/L VALUE IS INCORRECT. THE CORRECT VALUE IS 79 NG/L. (B)(4).

    Additional Manufacturer Narrative · 1

    RELEVANT RETENTION MATERIAL OF TNT TEST STRIP LOT 230756 WAS MEASURED ON A QUALIFIED COBAS H232 WITH: TWO NATIVE BLOOD SAMPLES AND TWO SPIKED BLOOD SAMPLES (C=80 NG/L AND C=90 NG/L). EACH SAMPLE WAS MEASURED THREE TIMES. THE BLOOD SAMPLES WERE ALSO MEASURED ON A COBAS E 411 IMMUNOASSAY ANALYZER (COBAS E411). RESULTS: MEAN OF THE MEASUREMENTS ON QUALIFIED COBAS H232: FIRST NATIVE BLOOD SAMPLE: <40 NG/L; SECOND NATIVE BLOOD SAMPLE: <40 NG/L; FIRST SPIKED BLOOD SAMPLE (C=80 NG/L): 75 NG/L; SECOND SPIKED BLOOD SAMPLE (C=90 NG/L): 100 NG/L. COBAS E411 MEASUREMENTS: FIRST NATIVE BLOOD SAMPLE: <3.00 PG/ML; SECOND NATIVE BLOOD SAMPLE: <3.00 PGM/L; FIRST SPIKED BLOOD SAMPLE (C=80 NG/L): 78.21 PG/ML; SECOND SPIKED BLOOD SAMPLE (C=90 NG/L): 97.09 PG/ML. THE RESULTS OF ALL MEASUREMENTS FULFILL REQUIREMENTS. THE CUSTOMER'S COBAS H 232 ANALYZER AND TEST STRIPS WERE RETURNED FOR INVESTIGATION. TEST STRIPS FROM THE CUSTOMER (LOT 230756) WERE MEASURED ON A COBAS H 232 FROM THE CUSTOMER AND ON A QUALIFIED COBAS H 232 WITH TWO NATIVE BLOOD SAMPLES AND TWO SPIKED BLOOD SAMPLES (C=85 NG/L AND C=80 NG/L). EACH SAMPLE WAS TESTED ONCE ON THE CUSTOMER'S COBAS H 232 ANALYZER AND ONCE ON A QUALIFIED COBAS H 232 ANALYZER. THE BLOOD SAMPLES WERE ALSO MEASURED ON A COBAS E411. RESULTS: MEASUREMENTS ON COBAS H232 FROM THE CUSTOMER: FIRST NATIVE BLOOD SAMPLE: <40 NG/L; SECOND NATIVE BLOOD SAMPLE: <40 NG/L; FIRST SPIKED BLOOD SAMPLE (C=85 NG/L): 86 NG/L; SECOND SPIKED BLOOD SAMPLE (C=80 NG/L): 76 NG/L. MEASUREMENTS ON QUALIFIED COBAS H232: FIRST NATIVE BLOOD SAMPLE: <40 NG/L; SECOND NATIVE BLOOD SAMPLE: <40 NG/L; FIRST SPIKED BLOOD SAMPLE (C=85 NG/L): 82 NG/L; SECOND SPIKED BLOOD SAMPLE (C=80 NG/L): 79 NG/L. COBAS E411 MEASUREMENTS: FIRST NATIVE BLOOD SAMPLE: <3.00 PG/ML; SECOND NATIVE BLOOD SAMPLE: 5.19 PG/ML; FIRST SPIKED BLOOD SAMPLE (C=85 NG/L): 81.97 PG/ML; SECOND SPIKED BLOOD SAMPLE (C=80 NG/L): 78.34 PG/ML. THE RESULTS OF ALL MEASUREMENTS FULFILL REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT TESTED FOR ROCHE CARDIAC TROP T (TNT) ON A COBAS H 232 ANALYZER. THE COBAS H 232 ANALYZER IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES, NOR IS IT LIKE OR SIMILAR TO A PRODUCT RELEASED FOR DISTRIBUTION IN THE UNITED STATES. TWO SAMPLES FROM THE PATIENT WERE TESTED ON THE COBAS H 232 ANALYZER. THE FIRST SAMPLE RESULTED AS < 40 NG/L AT 14:10 AND THE SECOND SAMPLE RESULTED AS < 40 NG/L AT 18:50. SAMPLES FROM THE PATIENT ALSO HAD TROPONIN TESTING PERFORMED ON THEM USING AN UNKNOWN LABORATORY METHOD. THE FIRST SAMPLE TESTED WITH THE LABORATORY METHOD RESULTED AS 86 NG/L AT 14:10. THE SECOND SAMPLE TESTED WITH THE LABORATORY METHOD RESULTED AS 76 NG/L AT 20:10. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AFTER CONSULTATION WITH A CARDIOLOGIST. A SAMPLE FROM THE PATIENT WAS TESTED AT THE HOSPITAL LABORATORY WITH AN UNKNOWN METHOD ON (B)(6) 2017 AT 10:20, RESULTING AS 85 NG/L. THE PATIENT WAS DISCHARGED ON (B)(6) 2017 WITH A PRINCIPAL DIAGNOSIS OF "NON-ACS TROPONIN RISE, POSSIBLY IN THE CONTEXT OF HYPOTHERMIA". NO ERRORS OCCURRED ON THE COBAS H 232 ANALYZER BEFORE AND AFTER PATIENT TESTING. THE NURSES BELIEVED THEY FOLLOWED THE CORRECT PROCEDURE WHEN PERFORMING THE TESTING ON THE COBAS H 232 ANALYZER. INTERNAL QUALITY CONTROLS WERE NOT RUN ON THE COBAS H 232 ANALYZER FOR THE MONTH OF DECEMBER, BUT INTERNAL QUALITY CONTROLS WERE WITHIN RANGE ON PREVIOUS MONTHS. EXTERNAL QUALITY CONTROL TESTING ON THE COBAS H 232 ANALYZER WAS UP TO DATE AND RESULTS WERE AS EXPECTED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE COBAS H 232 ANALYZER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9694 ROCHE CARDIAC TROP T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 23075611

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR