BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 502 MODULE

    MDR report key: 25001610 · Received April 27, 2026

    Report

    Report Number
    1823260-2026-01627
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM GEN.2 REAGENT LOT NUMBER WAS 882379. THE EXPIRATION DATE WAS NOT PROVIDED. THE QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER FOUND A FAILURE IN THE RINSE TUBING AND THE VALVE. HE REPLACED THE RINSE TUBING, THE ASSEMBLY, AND THE VALVE BASE. PRECISION STUDIES WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ASSAY ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 6.7 MG/DL. THE PATIENT WAS TESTED FOR CALCIUM AT THE EMERGENCY DEPARTMENT AND RECEIVED A "NORMAL" CALCIUM RESULT, PROMPTING THE PHYSICIAN TO REQUEST A REPEAT OF THE ORIGINAL SAMPLE. THE ORIGINAL SAMPLE WAS REPEATED TWICE ON A DIFFERENT COBAS C 502 MODULE, AND THE REPEAT RESULTS WERE 9.37 MG/DL AND 9.57 MG/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159970 COBAS 8000 COBAS C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1