BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23125772 · Received September 23, 2025

    Report

    Report Number
    1823260-2025-03516
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    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 CREATININE REAGENT LOT NUMBER WAS 873416. THE EXPIRATION DATE WAS NOT PROVIDED. THE CALCIUM REAGENT LOT NUMBER WAS 84136801 WITH AN EXPIRATION DATE OF 28-FEB-2026. THE FIELD SERVICE ENGINEER FOUND A HOLE IN THE TUBE ON THE RINSE STATION. HE REPLACED THE TUBE AND DID PREVENTIVE MAINTENANCE. THE INSTRUMENT WAS CONFIRMED TO BE PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER IN A REASONABLE AND COMMONLY TRAINED MANNER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE ROOT CAUSE WAS CONSISTENT WITH A HARDWARE-RELATED ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH CREATININE PLUS VER.2 ASSAY AND 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ASSAY ON A COBAS 8000 C702 MODULE (LINE 2). CREATININE: SAMPLE 1: INITIAL RESULT: 251 UMOL/L. 1ST REPEAT RESULT: 76 UMOL/L. 2ND REPEAT RESULT: 72 UMOL/L. SAMPLE 2: INITIAL RESULT: 203 UMOL/L. 1ST REPEAT RESULT: 67 UMOL/L. 2ND REPEAT RESULT: 67 UMOL/L. SAMPLE 3: INITIAL RESULT: 182 UMOL/L. 1ST REPEAT RESULT: 75 UMOL/L. 2ND REPEAT RESULT: 74 UMOL/L. THE HIGH RESULTS WERE QUESTIONED, PROMPTING THE RERUN. CALCIUM: SAMPLE 4: INITIAL RESULT: 0.43 MMOL/L. REPEAT RESULT: 2.42 MMOL/L. NO QUESTIONABLE RESULT FOR CALCIUM WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES ON THE C702 (LINE 1). THE REPEAT RESULTS WERE DEEMED TO BE CORRECT AS THEY WERE CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580541 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown