BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 502 MODULE

    MDR report key: 24815197 · Received April 8, 2026

    Report

    Report Number
    1823260-2026-01327
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928354
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHNY2 PHENYTOIN REAGENT LOT NUMBER IS 896041. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE PHNY2 PHENYTOIN ASSAY RESULTS FROM SEVERAL PATIENT SAMPLES COLLECTED IN SAMPLE TUBES WITH A GEL-SEPARATOR TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE REPORTER PROVIDED ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT FROM THE MODULE WAS 22 UG/ML THE REPEAT RESULT FROM ANOTHER COBAS ANALYZER WAS 31.3 UG/ML. THE PATIENT'S FAMILY QUESTIONED THE INITIAL RESULT AFTER RECEIVING THE RESULT OF A SECOND TEST. NO RESULT WAS DEEMED CORRECT, AS THE CUSTOMER BELIEVES THAT THE SEPARATOR GEL IN THE PATIENT SAMPLE TUBE MAY HAVE CAUSED THE QUESTIONABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162080 COBAS 8000 COBAS C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630928354

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male