BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 701 MODULE

    MDR report key: 21993807 · Received May 9, 2025

    Report

    Report Number
    1823260-2025-01437
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER WAS 836714. THE EXPIRATION DATE WAS NOT PROVIDED. THE ALBUMIN REAGENT LOT NUMBER WAS 832045 WTH AN EXPIRATION DATE OF 21-DEC-2025. THE GLUCOSE REAGENT LOT NUMBER WAS 828640 WITH AN EXPIRATION DATE OF 31-DEC-2025. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THE PROBE HAD NO SPRING IN ITS HEAD AND WAS STUCK IN THE UP POSITION. HE REPLACED THE SPRING IN THE PROBE HEAD AND CHECKED THE POSITIONS. HE PERFORMED PRECISION TESTING, AND THE CUSTOMER ACCEPTED ALL QC. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. PATIENT 1 INITIAL CREATININE PLUS VER.2 RESULT FOR A URINE SAMPLE WAS 5 MG/DL, AND THE REPEAT RESULT WAS 92 MG/DL. THE QUESTIONABLE RESULT FOR THIS SAMPLE WAS NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 INITIAL ALBUMIN GEN.2 RESULT WAS 5.7 MG/DL, AND THE REPEAT RESULT WAS 3.96 MG/DL. PATIENT 3 INITIAL GLUCOSE HK GEN.3 RESULT WAS 127 MG/DL, AND THE REPEAT RESULT WAS 79 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102707 COBAS 8000 COBAS C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female