BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 22553509 · Received July 21, 2025

    Report

    Report Number
    1823260-2025-02214
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UREA/BUN REAGENT LOT NUMBER IS 854085. THE CALCIUM GEN.2 REAGENT LOT NUMBER IS 850567. THE CREATININE JAFFE GEN.2 REAGENT LOT NUMBER IS 850584. THE EXPIRATION DATES WERE NOT PROVIDED. THE ISE INDIRECT NA-K-CL ELECTRODE SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE PROVIDED QC DATA, AND THE RESULTS WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE INVESTIGATED THE EVENT AND DETERMINED THAT THE CUSTOMER'S INCORRECT USE OF MICRCUPS HAD CAUSED IT. HE VERIFIED THE MODULE'S PERFORMANCE WITH SUCCESSFUL HARDWARE AND PRECISION CHECKS. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE UREA/BUN, CALCIUM GEN.2, CREATININE JAFFE GEN.2, ISE INDIRECT NA-K-CL FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. ONE PATIENT SAMPLE WITH DISCREPANT RESULTS WAS PROVIDED: UREA/BUN THE INITIAL RESULT FROM THE MODULE WAS 99 MG/DL. THE FIRST REPEAT RESULT FROM THE MODULE WAS 8 MG/DL THE SECOND REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 9 MG/DL. CALCIUM GEN 2 THE INITIAL RESULT FROM THE MODULE WAS 6.2 MG/DL. THE FIRST REPEAT RESULT FROM THE MODULE WAS 7.7 MG/DL THE SECOND REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 7.5 MG/DL. CREATININE THE INITIAL RESULT FROM THE MODULE WAS 13.13 MG/DL. THE FIRST REPEAT RESULT FROM THE MODULE WAS 0.45 MG/DL THE SECOND REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 0.45 MG/DL. CHLORIDE THE INITIAL RESULT FROM THE MODULE WAS 121 MMOL/L. THE FIRST REPEAT RESULT FROM THE MODULE WAS 109 MMOL/L THE SECOND REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 109 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY; THE HIGH POTASSIUM RESULTS PROMPTED THE RERUN OF THE PATIENT SAMPLES. THE SECOND REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037348 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female