BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 19539069 · Received June 14, 2024

    Report

    Report Number
    1823260-2024-01778
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER AGAIN AND REPLACED THE GEAR PUMP HEAD (GPH) AND THE REAGENT NOZZLES. HE THEN FLUSHED THE REAGENT PROBES AND THE SYRINGES/TUBING. HE ALSO CHECKED THE RINSE LEVELS, THE GPH PRESSURE, THE SYRINGE BREAKING, AND THE MIXING AND THEY WERE ACCEPTABLE. CALIBRATION AND QC WERE PERFORMED AND THEY WERE ACCEPTABLE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE ROOT CAUSE WAS CONSISTENT WITH A MAINTENANCE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED SINCE NO FURTHER ISSUES WERE REPORTED AND A CORRECT RERUN WAS PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) FOUND A FAULTY RIBBON CABLE. HE CORRECTED THE RIBBON CABLE. HE ALSO CLEANED THE CUVETTE WASH NOZZLES, CHECKED AND ADJUSTED THE PROBE WASHES, AND CHECKED THE PROBE ADJUSTMENTS AND THE CUVETTE WASH LEVELS. THE FSE THEN DID MECHANISM CHECKS AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. HE PERFORMED CALIBRATION AND QC AND THEY WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR MULTIPLE PATIENTS' URINE SAMPLES TESTED WITH CREATININE JAFFE ASSAY ON A COBAS 6000 C501 MODULE. DISCREPANT RESULTS FOR 1 PATIENT'S URINE SAMPLE WERE PROVIDED. INITIAL RESULT: 0.006. REPEAT RESULT: 6.341. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372914 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown