BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 22642352 · Received July 29, 2025

    Report

    Report Number
    1823260-2025-02329
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 12, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REAGENT/ELECTRODE LOT NUMBERS WERE PROVIDED: AST = 863374, TRIGLYCERIDES = 852875, TOTAL PROTEIN = 867699, HDL = 801357, GLUCOSE = 849768, SODIUM = DKK89, POTASSIUM = DQS33, CHLORIDE = DEN77, ALT = 865073. THE REAGENT/ELECTRODE EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE LAST REAGENT CALIBRATIONS PERFORMED WERE ACCEPTABLE. A REVIEW OF ALARM TRACE DATA DID NOT SHOW ANY RELEVANT ALARMS. THE FIELD SERVICE ENGINEER FOUND FLUIDIC LEAKS, A CRACKED DIAPHRAGM, AND A BLOCKED VACUUM TANK ELBOW. THE AFFECTED PARTS WERE REPLACED. THE VACUUM TANK ELBOW WAS CLEANED. PRECISION STUDIES WERE RUN AND PASSED. CONTROLS WERE RUN AND WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THEY REPEATED TESTING FOR PATIENT SAMPLES TESTED ON (B)(6) 2025 DUE TO INSTRUMENT ISSUES WITH THE COBAS 6000 C (501) MODULE. THE SAMPLES WERE REPEATED ON A SECOND ANALYZER AND THE REPEAT VALUES WERE BELIEVED TO BE CORRECT. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENT SAMPLES THAT HAD DISCREPANT RESULTS. RESULTS FROM THE FOLLOWING ASSAYS WERE AFFECTED: ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, TRIGLYCERIDES, TOTAL PROTEIN GEN.2, HDL-CHOLESTEROL GEN.4, GLUCOSE HK GEN. 3, SODIUM ELECTRODE, POTASSIUM ELECTRODE, CHLORIDE ELECTRODE, AND ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 14.2 U/L AND IT REPEATED AS 22.2 U/L. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 193 MG/DL AND IT REPEATED AS 363 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THIS SAMPLE. THE THIRD PATIENT SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 5.0 G/DL AND IT REPEATED AS 7.1 G/DL. THE FOURTH PATIENT SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: HDL = 25 MG/DL, TOTAL PROTEIN = 5.3 MG/DL, GLUCOSE = 78 MG/DL, SODIUM = 112 MMOL/L, ALT = 20.4 U/L, AST = 18.9 U/L, POTASSIUM = 3.52 MMOL/L, CHLORIDE = 81.2 MMOL/L. THE FOURTH PATIENT SAMPLE REPEATED WITH THE FOLLOWING VALUES: HDL = 42 MG/DL, TOTAL PROTEIN = 7.1 MG/DL, GLUCOSE = 105 MG/DL, SODIUM = 138 MMOL/L, ALT = 37.9 U/L, AST = 36.4 U/L, POTASSIUM = 4.60 MMOL/L, CHLORIDE = 102.9 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086634 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female