BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22134916 · Received June 3, 2025

    Report

    Report Number
    1823260-2025-01713
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 4, 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

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) HOSPITAL. THE REAGENT LOT NUMBER IS 841368. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE REPLACED THE REAGENT PROBES AND THE CUVETTE WASHING STATION'S TUBING. HE PERFORMED ADJUSTMENTS AND CHECKS, AN INCUBATION WATER EXCHANGE, AND CELL BLANK MEASUREMENTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MEDWATCH, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE." INSTEAD OF: "THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE."

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. PATIENT 1: THE INITIAL RESULT WAS 1.51 MMOL/L, AND THE REPEATED RESULT WAS 2.09 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 1.42 MMOL/L, AND THE REPEATED RESULT WAS 2.16 MMOL/L. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065008 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown