BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 20929364 · Received December 13, 2024

    Report

    Report Number
    1823260-2024-03680
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 30, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630929764
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN T REAGENT LOT NUMBER WAS 74311200. THE HCG REAGENT LOT NUMBER WAS 70917400. THE EXPIRATION DATES WERE NOT PROVIDED. THE QC RECOVERY WAS WITHIN THE PROVIDED RANGES BEFORE THE EVENT. THE ANALYZER ALARM TRACE CONTAINED ABNORMAL SAMPLE ASPIRATION, ABNORMAL ASPIRATION (SAMPLE PROBE), AND ABNORMAL ASPIRATION (SAMPLE PROBE A/B) ERRORS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER FOUND A THREAD AT THE END OF THE REAGENT PROBE WAS CAUSING DROPLETS. HE CLEANED THE INSIDE AND OUTSIDE OF THE REAGENT PROBE AND ADJUSTED THE OUTSIDE RINSE. HE CLEANED THE SAMPLE PROBE AND PERFORMED MECHANICAL ADJUSTMENTS. HE RAN PRECISION STUDIES FOR HCG AND TROPONIN WHICH PASSED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. PATIENT 1 INITIAL TROPONIN T GEN5 STAT ELECSYS RESULT WAS 10 NG/L AND THE REPEAT RESULT WAS 422 NG/L. PATIENT 2 INITIAL HCG+BETA ELECSYS RESULT WAS 0.6 MIU/ML AND THE REPEAT RESULT WAS 120273 MIU/ML. THE REPEAT RESULTS WERE BELIEVED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923956 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630929764

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male