BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS C-PEPTIDE

    MDR report key: 22983126 · Received September 5, 2025

    Report

    Report Number
    1823260-2025-02772
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE ALARM TRACE SHOWED A REAGENT KIT ALARM (REAGENT PROBE). NO ISSUE WAS OBSERVED WITH THE REAGENT NEEDLE. THE PRE-ANALYTIC DATA SHOWED THAT THE SERUM HAD NO CLOTS OR BLOOD STREAKS. THE CUSTOMER REPLACED THE REAGENT WITH ANOTHER REAGENT PACK OF THE SAME LOT. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED, BECAUSE ANOTHER REAGENT KIT OF THE SAME LOT PERFORMED ACCORDING TO EXPECTATIONS AT THIS CUSTOMER¿S SITE. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED, ALTHOUGH THE ISSUE IS CONSISTENT WITH A TRANSPORTATION/STORAGE ISSUE. THE ISSUE WAS RESOLVED BY USING ANOTHER REAGENT PACK OF THE SAME LOT.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS C-PEPTIDE ASSAY ON A COBAS E 801 MODULE. SAMPLE 1: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 1096 NMOL/L. SAMPLE 2: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 468 NMOL/L. SAMPLE 3: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 1619 NMOL/L. SAMPLE 4: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 876 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133133 ELECSYS C-PEPTIDE C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY JKD ROCHE DIAGNOSTICS 77777801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown