BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 701 MODULE

    MDR report key: 24686335 · Received March 25, 2026

    Report

    Report Number
    1823260-2026-01065
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHOLESTEROL REAGENT LOT NUMBER WAS 922879. THE EXPIRATION DATE WAS NOT PROVIDED. THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION WAS ACCEPTABLE. ACCORDING TO THE PROVIDED PRE-ANALYTICAL DATA, THE CUSTOMER DID NOT USE THE REQUIRED RACK ADAPTERS FOR 13X75 MM TUBES. NO FURTHER ISSUES WERE REPORTED AFTERWARDS. A GENERAL ANALYZER PROBLEM CAN BE EXCLUDED, SINCE THE QC PRIOR TO THE EVENT WAS WITHIN THE RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED, BUT IT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ASSAY ON A COBAS 8000 COBAS C 701 MODULE. INITIAL RESULT: <0.0386 G/L. DURING THE VALIDATION OF THE RESULT, THE VALUE WAS DEEMED UNBELIEVABLE, PROMPTING THE REPEAT OF THE SAMPLE ON A DIFFERENT COBAS ANALYZER. REPEAT RESULT: 1.70 G/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746337 COBAS 8000 COBAS C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female