BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 6581856 · Received May 22, 2017

    Report

    Report Number
    1823260-2017-01068
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 22, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW RESULTS FOR TWO PATIENT SAMPLES USING THE CA2 CALCIUM GEN.2 ASSAY (CA2) ON THE COBAS 8000 C (701) MODULE. ALL RESULTS ARE IN UNITS OF MMOL/L, AND ALL WERE RELEASED OUTSIDE OF THE LABORATORY TO THE CLINICIAN. PATIENT A: THE INITIAL RESULT WAS 2.02; THE REPEAT RESULT WAS 2.61. PATIENT B: THE INITIAL RESULT WAS 2.02; THE REPEAT RESULT WAS 2.59. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CA2 REAGENT LOT NUMBER IS 200966 WITH AN EXPIRATION DATE OF 02/28/2018. THE CUSTOMER STATED THAT NON-ROCHE QUALITY CONTROLS (QC) WERE ERRATIC ON ALL LEVELS. THE CUSTOMER WAS INSTRUCTED TO CHANGE THE SAMPLE PROBE AND RUN ROCHE QC FOR A FEW DAYS TO MONITOR RECOVERY. NO INFORMATION WAS PROVIDED TO INDICATE THAT THE CUSTOMER TOOK THESE ACTIONS. ON 05/04/2017, THE FIELD SERVICE REPRESENTATIVE REPLACED THE SAMPLE PIPETTOR FOR A SEPARATE ISSUE. THE CUSTOMER WAS CONVINCED THAT THIS ACTION RESOLVED THE ISSUE WITH QUESTIONABLE RESULTS, SINCE NON-ROCHE QC WAS NOW BACK IN RANGE. THE CUSTOMER STATED THAT THE ISSUE WAS SOLVED DUE TO MAINTENANCE AND REFUSED ADDITIONAL INVESTIGATION. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362351 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1