BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22966924 · Received September 4, 2025

    Report

    Report Number
    1823260-2025-02747
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 7, 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 REAGENT LOT NUMBER WAS 812051. THE EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING. E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6).

    Additional Manufacturer Narrative · 0

    REAGENT ISSUES WERE EXCLUDED AS NO FURTHER CASES WERE REPORTED, AND CORRECT RERUNS WERE PERFORMED WITH THE SAME REAGENT. THE CUSTOMER CONFIRMED THAT THE EVENT WAS DUE TO A PATIENT SAMPLE-SPECIFIC ISSUE. A FIELD SERVICE ENGINEER (FSE) COMPLETED A CHECK OF THE SYSTEM AND CONFIRMED THAT TESTS AND THE MODULE ARE RUNNING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE EVENT WAS DUE TO A PATIENT SAMPLE-SPECIFIC ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS WITH ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS <0.11 MMOL/L. THE FIRST REPEAT RESULT WAS <0.11 MMOL/L. THE SECOND REPEAT RESULT WAS 6.89 MMOL/L. THE THIRD REPEAT RESULT WAS 6.85 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018593 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown