BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 20694117 · Received November 15, 2024

    Report

    Report Number
    1823260-2024-03330
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER IS 803139. THE TRIGL REAGENT LOT NUMBER AND THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. THE GLUC3 CALIBRATION AND BOTH REAGENTS' QC RECOVERY DATA WERE ACCEPTABLE. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. THE FIELD SERVICE ENGINEER (FSE) CHANGED THE WATER FILTERS, INCREASED THE PRESSURE IN THE DETERGENT AND WATER DISPENSING PROBES, CHECKED THE GEAR PUMP, CUVETTES, AND RINSE BATH, AND CLEANED AND PURGED ALL PIPETTES. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 AND TRIGL TRIGLYCERIDES RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. FOR SAMPLE 1, THE INITIAL GLU3 RESULT WAS 6.5 MG/DL. THE REPEAT RESULT WAS 146.1 MG/DL. FOR SAMPLE 2, THE INITIAL TRIGL RESULT WAS 606.8 MG/DL. THE REPEAT RESULT WAS 93.7 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195388 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female ENALAPRIL (PATIENT 2)| LEVOTIROXINA (PATIENT 2)