BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE CARDIAC TROP T

    MDR report key: 8150042 · Received December 11, 2018

    Report

    Report Number
    1823260-2018-04751
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 21, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE SAMPLES WERE RUN ON A COBAS E411 INSTRUMENT AT THE INVESTIGATION SITE: FIRST TUBE: < 3.00 PG/ML , SECOND TUBE: < 3.00 PG/ML , THIRD TUBE: < 3.00 PG/ML . ONE NATIVE BLOOD SAMPLE WAS SPIKED WITH SAMPLES FROM THE PATIENT (FIRST, SECOND AND THIRD TUBE) AND WERE MEASURED ON A QUALIFIED COBAS H232 METER AT THE INVESTIGATION SITE (N= ONE TEST STRIP PER SPIKED BLOOD SAMPLE WITH THE MASTER LOT ROCHE CARDIAC POC TROPONIN T OF LOT 28237880: MEASUREMENTS ON QUALIFIED COBAS H232: SPIKED BLOOD SAMPLE, FIRST TUBE: < 40 NG/L, SPIKED BLOOD SAMPLE, SECOND TUBE: < 40 NG/L , SPIKED BLOOD SAMPLE, THIRD TUBE: < 40 NG/L. ROCHE CARDIAC POC TROPONIN T STRIP LOT 28237880 WAS MEASURED ON THE COBAS H232 FROM THE CUSTOMER AND ON A QUALIFIED COBAS H232 AT THE INVESTIGATION SITE WITH THREE NEGATIVE BLOOD SAMPLES AND ONE SPIKED BLOOD SAMPLE (C=140 NG/L), EACH BLOOD SAMPLE N=THREE TEST STRIPS WITH EACH METER. MEAN OF THE MEASUREMENTS ON THE COBAS H232 FROM THE CUSTOMER: FIRST NEGATIVE BLOOD SAMPLE: < 40 NG/L, SECOND NEGATIVE BLOOD SAMPLE: < 40 NG/L , THIRD NEGATIVE BLOOD SAMPLE: < 40 NG/L, SPIKED BLOOD SAMPLE (C=140 NG/L): 149 NG/L. MEAN OF THE MEASUREMENTS ON THE QUALIFIED COBAS H232 AT THE INVESTIGATION SITE: FIRST NEGATIVE BLOOD SAMPLE: < 40 NG/L, SECOND NEGATIVE BLOOD SAMPLE: < 40 NG/L, THIRD NEGATIVE BLOOD SAMPLE: < 40 NG/L , SPIKED BLOOD SAMPLE (C=140 NG/L): 146 NG/L. THE MASTER LOT MEASUREMENT RESULTS BETWEEN THE COBAS H232 FROM THE CUSTOMER AND THE QUALIFIED COBAS H232 AT THE INVESTIGATION SITE FULFILL THE REQUIREMENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). - ATTACHMENT: [OTHERRELEVANTTESTSQ-250059.PDF]

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT TROPONIN T RESULTS FOR 1 PATIENT TESTED ON A COBAS H232 METER COMPARED TO A COBAS E 411 IMMUNOASSAY ANALYZER. THE PATIENT WAS TESTED ON THE H232 METER AND THE RESULT WAS 116 NG/L. THE RESULT FROM THE E411 ANALYZER WAS < 3 NG/L. THE PATIENT WAS TESTED A 2ND TIME ON THE H232 METER WITH A RESULT OF 245 NG/L. THE RESULT FROM THE E411 ANALYZER WAS < 3 NG/L. THE PATIENT WAS TESTED A 3RD TIME ON THE H232 METER WITH A RESULT OF 111 NG/L. THE RESULT FROM THE E411 ANALYZER WAS < 3 NG/L. THE TIME-FRAME BETWEEN THE RESULTS FROM THE H232 METER AND THE E411 ANALYZER WAS 15-20 MINUTES. THE DIFFERENCE IN RESULTS BETWEEN THE H232 METER AND THE E411 ANALYZER WERE "TOO BIG" AND THE DOCTOR "HANDLED" THE PATIENT BASED ON THE RESULTS FROM THE E411 ANALYZER. THE DOCTOR QUESTIONED THE RESULTS FROM THE H232 METER. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER RAN QC AFTER THE RESULTS AND THE RESULT WAS WITHIN THE ACCEPTABLE RANGE. INTERNAL QC RESULTS WERE OK. THE H232 METER SERIAL NUMBER WAS (B)(4). NEITHER THE H232 INSTRUMENT NOR A SIMILAR DEVICE IS SOLD IN THE UNITED STATES. THE FIELD APPLICATION SPECIALIST (FAS) VISITED THE CUSTOMER SITE AND PERFORMED A COMPARISON TEST WITH 4 PATIENT SAMPLES BETWEEN THE H232 INSTRUMENT AND THE E411 ANALYZER. THE RESULTS WERE COMPARABLE TO ONE ANOTHER. THE CUSTOMER IS QUESTIONING WHY THERE WAS SUCH A DIFFERENCE IN THE RESULTS FOR THE INITIAL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990481 ROCHE CARDIAC TROP T IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1