BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 701 MODULE

    MDR report key: 24886129 · Received April 15, 2026

    Report

    Report Number
    1823260-2026-01427
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE PLUS VER.2 REAGENT LOT NUMBER IS 916764, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) REAGENT LOT NUMBER IS 922943, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 AND ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE FOR APPROXIMATELY 15 PATIENTS. RESULTS FOR 5 PATIENTS ARE PROVIDED AS REPRESENTATIVE EXAMPLES. PATIENT 1'S INITIAL CREATININE RESULT ON ANOTHER C 701 ANALYZER WAS 78 UMOL/L. RESULTS FROM A PRE-DILUTED SAMPLE ON THE COMPLAINED C 701 ANALYZER WERE 418 UMOL/L AND 76 UMOL/L. PATIENT 2'S INITIAL CREATININE RESULT ON (B)(6) 2026 WAS 383 UMOL/L. A REPEAT RESULT ON ANOTHER ANALYZER WAS 51 UMOL/L. THE REPEAT RESULTS ON (B)(6) 2026 ON ANOTHER C 701 ANALYZER WERE 51 UMOL/L AND 49 UMOL/L. PATIENT 3'S INITIAL CREATININE RESULT ON (B)(6) 2026 WAS 1089 UMOL/L, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 401 UMOL/L. PATIENT 4'S INITIAL CREATININE RESULT ON (B)(6) 2026 WAS 556 UMOL/L, ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 63 UMOL/L. THE REPEAT RESULT ON ANOTHER C 701 ANALYZER WAS 66 UMOL/L. PATIENT 5'S INITIAL AST RESULT ON (B)(6) 2026 WAS 7 U/L, ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 27 U/L. THE REPEAT RESULT ON ANOTHER C 701 ANALYZER WAS 29 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502356 COBAS 8000 COBAS C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1