BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1652532 · Received April 7, 2010

    Report

    Report Number
    1823260-2010-02048
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 16, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    USER EXPERIENCED LOW SODIUM RECOVERY. USER SAID HE RAN A "FEW" PATIENT SAMPLES FOR SODIUM COMPARISON WITH ANOTHER ANALYZER (DADE EXPAND) AND SODIUM RESULTS FROM THE I800 (B) (4) WERE LOWER THAN RESULTS FROM THE DADE EXPAND. ONLY 1 PATIENT EXAMPLE WAS PROVIDED WHICH WAS DISCREPANT. INITIAL RESULT FROM I800 GAVE 134 MMOL/L; REPEAT ON DADE EXPAND GAVE 140 MMOL/L. USER SAID HE DID NOT REPORT ANY OF THE PATIENT SODIUM RESULTS FROM THE INTEGRA 800. SODIUM ELECTRODE LOT NUMBER: 21592526. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE APPEARED TO BE RELATED TO THE SODIUM ELECTRODE. THE CUSTOMER REPLACED THE SODIUM ELECTRODE AND IT WAS CURRENTLY WORKING PROPERLY. THE FSR REPLACED TUBING, CHECKED MIXING VESSEL FOR CLOGS, CHECKED MIX AND DRY SPECS AND ADJUSTED DRY, MIX WAS OK. CUSTOMER RAN CONTROLS AND BOTH LEVELS RECOVERED ON MEAN. COMPARED PATIENT SODIUM RESULTS BETWEEN I800 AND DADE EXPAND WHICH COMPARED ACCEPTABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1