BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 19665824 · Received July 3, 2024

    Report

    Report Number
    1823260-2024-01928
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALB2 REAGENT LOT NUMBER WAS 775874 WITH AN EXPIRATION DATE OF 30-APR-2025. THE GLUC HK REAGENT LOT NUMBER WAS 754374 WITH AN EXPIRATION DATE OF 31-JAN-2025. THE TP2 REAGENT LOT NUMBER WAS 760198 WITH AN EXPIRATION DATE OF 28-FEB-2025. THE K ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CUSTOMER WAS RECEIVING "ABNORMAL PROBE SUCKING" ALARMS. ON (B)(6) 2024 THE CUSTOMER PERFORMED MONTHLY AND WEEKLY MAINTENANCE AND CHANGED THE ELECTRODES. THE FIELD SERVICE ENGINEER (FSE) FOUND THE RINSE TUBING WAS TORN AND NOT FUNCTIONING CORRECTLY. THE FSE REPLACED THE RINSE TUBING. THE FSE RAN A 21-CUP PRECISION WITH RESULTS WITHIN SPECIFICATION. THE CUSTOMER HAS HAD NO FURTHER ISSUES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION WAS ACCEPTABLE FOR ALL INVOLVED TESTS. QC WAS ACCEPTABLE. THERE IS NO INDICATION OF A REAGENT/ELECTRODE PERFORMANCE ISSUE. MULTIPLE "SAMPLE SHORT" ALARMS WERE OBSERVED ON THE DAY OF THE EVENT NEAR THE TIME THE SAMPLES WERE PROCESSED. THE SERVICE ACTIONS (REPLACING THE RINSE TUBING) RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENTS TESTED FOR MULTIPLE ASSAYS ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 5 PATIENT SAMPLES TESTED FOR K ELECTRODE (K), COBAS INTEGRA GLUCOSE HK GEN. 3 (GLUC HK), TOTAL PROTEIN/TOTAL PROTEIN STAT (TP2) AND ALB2 ALBUMIN GEN.2 (ALB2). "SAMPLE 3" INITIAL GLUC HK RESULT WAS < 2 MG/DL. THE REPEAT RESULT WAS 163 MG/DL. "SAMPLE 4" INITIAL TP2 RESULT WAS 0.2 G/DL. THE REPEAT RESULT WAS 6.6 G/DL. "SAMPLE 5" INITIAL ALB2 RESULT WAS < 0.2 G/DL. THE REPEAT RESULT WAS 4.4 G/DL. "SAMPLE 6" INITIAL GLUC HK RESULT WAS < 2 MG/DL. THE REPEAT RESULT WAS 403 MG/DL. "SAMPLE 9" INITIAL K RESULT WAS 8 MMOL/L. THE REPEAT RESULT WAS 4 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER NOTICED "SOME VERY LOW" RESULTS AND REPEATED THE SAMPLES TO DOUBLE-CHECK THE RESULTS. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759329 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown