BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 15312790 · Received August 29, 2022

    Report

    Report Number
    1823260-2022-02617
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    July 21, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN WHETHER THE MEDICATION OF VITAMIN B 6 WAS GIVEN AFTER THE SAMPLE WAS TAKEN OR BEFORE. IT IS ALSO NOT KNOWN WHETHER THE MEDICATION IS CONTINUOUSLY TAKEN. A RE-RUN OF THE SAME SAMPLE ON COBAS 8000 C 702 MODULE RESULTED IN A VALUE OF 37.9 MOL/L. CALIBRATION DATA WERE WITHIN THE EXPECTED RANGES. QUALITY CONTROL RECOVERY WAS WITHIN SPECIFICATION ON THE DATE OF THE EVENT. UPON REVIEW OF THE ALARM TRACE FROM 21-JUL-2022, THERE WERE MULTIPLE ABNORMAL ASPIRATION ALARMS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC HANDLING OF THE SAMPLE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE HCYS (HOMOCYSTEINE ENZYMATIC) ASSAY ON A COBAS 8000 C 702 MODULE COMPARED TO THE RESULT OBTAINED WITH HPLC (HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY). THE SAMPLE INITIALLY RESULTED IN AN HYCS VALUE OF 7.6 MOL/L. REPETITION OF THE SPECIMEN CONFIRMED THIS VALUE. THE SAMPLE WAS MEASURED USING THE HPLC TECHNIQUE, RESULTING IN A VALUE OF 40 MOL/L. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE HYCS REAGENT LOT NUMBER WAS 571023, WITH AN EXPIRATION DATE OF 31-AUG-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344116 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown