BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21900093 · Received April 24, 2025

    Report

    Report Number
    1823260-2025-01263
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 8, 2025
    Report Date
    June 13, 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

    MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THERE WAS AN ALLEGATION OF ADDITIONAL QUESTIONABLE RESULTS FROM THE COBAS 8000 C702 MODULE. PATIENT SAMPLE 2: ON (B)(6) 2025, THE INITIAL CREATININE PLUS VER.2 RESULT WAS 98 MOL/L, AND THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 77 MOL/L. THE CREATININE REAGENT LOT NUMBER WAS 853137. THE EXPIRATION DATE WAS NOT PROVIDED. PATIENT SAMPLE 3: ON (B)(6) 2025, THE INITIAL CALCIUM RESULT WAS 1.62 MMOL/L, AND THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 2.28 MMOL/L. THE REPEAT RESULT FROM THE ORIGINAL ANALYZER WAS 2.25 MMOL/L. THE CALCIUM REAGENT LOT NUMBER WAS 841368. THE EXPIRATION DATE WAS NOT PROVIDED. PATIENT SAMPLE 4: ON (B)(6) 2025, THE INITIAL GLUCOSE RESULT WAS 0.75 MMOL/L, AND THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 6.65 MMOL/L. THE GLUCOSE REAGENT LOT NUMBER WAS 828640. THE EXPIRATION DATE WAS NOT PROVIDED. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE AND REPLACED ALL DIAPHRAGMS IN VACUUM PUMPS. HE RAN BLANK CELL CHECKS THAT WERE ACCEPTABLE. THE CUSTOMER PERFORMED CALIBRATION AND QC. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 33. THE REPEAT RESULT WAS 165. THE UNIT OF MEASURE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289196 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown