BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 6399306 · Received March 13, 2017

    Report

    Report Number
    1823260-2017-00548
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 23, 2017
    Report Date
    April 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS DID NOT SHOW THE SAME LOW RECOVERY OBSERVED WITH THE PATIENT SAMPLE. THEREFORE, THE ISSUE LIKELY DOES NOT AFFECT INSTRUMENT PERFORMANCE IN GENERAL. FLUCTUATIONS WERE SEEN WITH CRP CALIBRATIONS AND THESE FLUCTUATIONS MAY POSSIBLY BE CAUSED BY FLUCTUATING WATER QUALITY. THE ISSUE MAY HAVE BEEN RELATED TO PRE-ANALYTIC SAMPLE HANDLING. THERE WAS NO INDICATION OF A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR UA2 URIC ACID VER.2 (UA) AND CRPL3 C-REACTIVE PROTEIN GEN.3 (CRP) ON A COBAS 8000 C (701) MODULE - C701. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE ISSUE OCCURRED ONLY ONCE AND THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL ISSUES. THE SAMPLE INITIALLY RESULTED AS 0 UMOL/L FOR UA AND 0.33 MG/L FOR CRP. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 426 UMOL/L FOR UA AND 108.71 MG/L FOR CRP. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE UA REAGENT LOT NUMBER WAS 204382 AND THE CRP REAGENT LOT NUMBER WAS 202453. THE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180914 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR