BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTEROL GEN.2

    MDR report key: 22326945 · Received June 25, 2025

    Report

    Report Number
    1823260-2025-01940
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 31, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHH
    UDI-DI
    04015630918430
    PMA / PMN Number
    K031824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. PRECISION RESULTS WERE WITHIN SPECIFICATION. THE CUSTOMER REPEATED OTHER PATIENT SAMPLES TESTED FOR CHOL2 ON 30-MAY-2025, 31-MAY-2025, AND 01-JUN-2025, AND THE RESULTS WERE REPRODUCIBLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. A GENERAL REAGENT PROBLEM WAS EXCLUDED AS CALIBRATION AND QC WERE ACCEPTABLE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CHOLESTEROL GEN.2 (CHOL2) ON A COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 15.49 MMOL/L. ON 02-JUN-2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS 5.44 MMOL/L. THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 5.72 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361012 CHOLESTEROL GEN.2 ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL CHH ROCHE DIAGNOSTICS 836489 04015630918430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown