BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC TROP T

    MDR report key: 7392619 · Received April 3, 2018

    Report

    Report Number
    1823260-2018-01046
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 25, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION AND WERE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE RESULTS WERE 21.03 PG/ML, 20.93 PG/ML, 17.27 PG/ML, AND 17.70 PG/ML. TWO NATIVE BLOOD SAMPLES WERE SPIKED WITH TWO SAMPLES FROM THE PATIENT AND WERE MEASURED ON BOTH COBAS H232 METERS RETURNED FROM THE CUSTOMER AND WITH TEST STRIPS RETURNED BY THE CUSTOMER. THE RESULTS FROM METER KS0211257 WITH STRIP LOT 26756610 WERE BOTH <40 NG/L. THE RESULTS WITH METER KS0211690 WITH STRIP LOT 28718610 WERE BOTH <40 NG/L. ONE NATIVE BLOOD SAMPLE AND ONE SPIKED BLOOD SAMPLE WERE TESTED WITH THE CUSTOMER'S TEST STRIPS AND COBAS H232 METERS. WITH METER KS0211257 AND TEST STRIP LOT 6756610, THE NATIVE BLOOD SAMPLE RESULT WAS <40 NG/L AND THE SPIKED BLOOD SAMPLE RESULT WAS 503 NG/L. WITH METER KS0211690 AND TEST STRIP LOT 28718610, THE NATIVE BLOOD SAMPLE RESULT WAS <40 NG/L AND THE SPIKED BLOOD SAMPLE RESULT WAS 501 NG/L. WITH RELEVANT RETENTION MATERIAL AND QUALIFIED COBAS H232, THE NATIVE BLOOD SAMPLE RESULTS ON BOTH METERS WERE <40 NG/L. THE SPIKED BLOOD SAMPLE RESULTS WERE 498 NG/L AND 493 NG/L. FROM THE COBAS E 411 IMMUNOASSAY ANALYZER, THE RESULT FOR THE NATIVE BLOOD SAMPLE WAS <3.00 PG/ML AND THE RESULT FOR THE SPIKED BLOOD SAMPLE WAS 500.2 PG/ML. THE RESULTS FOR ALL OF THE INVESTIGATION WERE WITHIN SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6). EXPIRATION DATE NULL WAS PROVIDED AS "(B)(6)".

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TROPONIN T RESULTS FOR ONE PATIENT FROM COBAS H 232 METERS AND SUSPECTED INTERFERENCE. THE COBAS H232 METER IS NOT APPROVED FOR DISTRIBUTION NOR IS LIKE OR SIMILAR TO A PRODUCT APPROVED FOR DISTRIBUTION IN THE UNITED STATES. THE MEDWATCHS INVOLVED IN THIS EVENT INCLUDE PATIENT IDENTIFIERS (B)(6). THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. TROPONIN T WAS TESTED IN THE EMERGENCY DEPARTMENT (ED) USING METER SERIAL NUMBER (B)(4) AND STRIP LOT 28718611. THE RESULT AT 10:35AM WAS 485 NG/L. THE TROPONIN T HS RESULT FROM THE LABORATORY 11.32AM WAS <29 NG/L (20.72 NG/L). A "6 HOUR" TROPONIN T TEST WAS PERFORMED AT 4:00PM ON THE ED COBAS H232 METER SERIAL NUMBER (B)(4) AND TEST STRIP LOT 2871861 AND THE RESULT WAS 420 NG/L. THE SAMPLE WAS ALSO TESTED ON THE SPECIAL CARE WARD COBAS H232 METER SERIAL NUMBER (B)(4) AND TEST STRIP LOT 26756610. THE RESULT WAS 496 NG/L. THE TROPONIN T HS RESULT FROM THE LABORATORY WAS <29 NG/L (25.10 NG/L). THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER TESTED THE PATIENT'S SERUM PRE AND POST BLOCKING ANTIBODIES AND THERE WAS A SIGNIFICANT DIFFERENCE. THE CUSTOMER SUSPECTED THE PATIENT HAD CIRCULATING HETEROPHILE OR ANTI-MOUSE ANTIBODIES. THE CUSTOMER BELIEVED THE LOW TROPONIN T HS RESULTS WERE MORE CONSISTENT WITH THE CLINICAL PICTURE. RELEVANT RETENTION MATERIAL ROCHE CARDIAC POC TROPONIN T OF LOT 26756610 AND 28718610 WERE MEASURED ON QUALIFIED COBAS H232 WITH TWO SPIKED BLOOD SAMPLES (C=480 NG/L AND C=420 NG/L) AND ONE NATIVE BLOOD SAMPLE. MEAN WITH LOT 26756610: FIRST SPIKED BLOOD SAMPLE (C=480 NG/L): 480 NG/L, SECOND SPIKED BLOOD SAMPLE (C=420 NG/L): 428 NG/L, NATIVE BLOOD SAMPLE: <40 NG/L. MEAN WITH LOT 28718610: FIRST SPIKED BLOOD SAMPLE (C=480 NG/L): 483 NG/L, SECOND SPIKED BLOOD SAMPLE (C=420 NG/L): 432 NG/L, NATIVE BLOOD SAMPLE: <40 NG/L. COBAS E411 MEASUREMENTS: FIRST SPIKED BLOOD SAMPLE (C=480 NG/L): 475.1 PG/ML, SECOND SPIKED BLOOD SAMPLE (C=420 NG/L): 417.9 PG/ML, NATIVE BLOOD SAMPLE: <3.00 PG/ML. THE RESULTS OF ALL MEASUREMENTS FULFILL THE REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236907 ROCHE CARDIAC TROP T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 26756610

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR