BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS C-PEPTIDE

    MDR report key: 22664595 · Received July 30, 2025

    Report

    Report Number
    1823260-2025-02351
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JKD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THERE WAS NO CALIBRATION INFLUENCE OBSERVED. THE QC WAS WITHIN RANGE PRIOR TO THE SAMPLE MEASUREMENT. THERE WAS NO DATA ALARM FOR SUCTION ABNORMALITY AT THE TIME OF THE INITIAL TEST MEASUREMENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ADDITIONAL DISCREPANT ELECSYS C-PEPTIDE RESULTS FROM A DIFFERENT URINE SAMPLE FROM THE SAME PATIENT: ON 19-JUN-2025, THE INITIAL RESULT WAS 0.4 NG/ML. ON 20-JUN-2025, THE REPEAT RESULT WAS 134 NG/ML. THE PHYSICIAN DETERMINED THAT THE REPEAT RESULT WAS CORRECT. THE PROVIDED RESULT DATA PRINTOUT SHOWED NUMEROUS DATA ALARMS, WHICH INDICATE THAT AN EXPIRED REAGENT WAS USED FOR THE ASSAY. THE FIELD SERVICE ENGINEER INVESTIGATED THE EVENT AND DETERMINED THAT IT WAS CAUSED BY THE CUSTOMER'S USE OF AN EXPIRED ASSAY DILUIENT. THE DILUENT WAS REPLACED AND SUCCESSFUL REPEATABILITY TESTS WERE PERFORMED. PRODUCT LABELING STATES: "DILLUENT MULTIASSAY STORAGE AND STABILITY STORE AT 2-8 °C. STABILITY: UNOPENED AT 2-8 °C UP TO THE STATED EXPIRATION DATE. ON THE COBAS E 402 AND COBAS E 801 ANALYZER - 16 WEEKS." THE CAUSE OF THE EVENT WAS DUE TO AN OFF-LABEL USE (THE CUSTOMER USED AN EXPIRED ASSAY DILUENT). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS C-PEPTIDE ASSAY ON A COBAS E 801 MODULE. INITIAL RESULT: 0.7 NG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, PROMPTING THE REPEAT OF THE SAMPLE. REPEAT RESULT: 23.2 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54826 ELECSYS C-PEPTIDE C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY JKD ROCHE DIAGNOSTICS 83114202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown