BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 6031333 · Received October 14, 2016

    Report

    Report Number
    1823260-2016-01573
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    October 2, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BASED ON THE DATA PROVIDED, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. AS BOTH SODIUM AND POTASSIUM WERE AFFECTED, IT WAS MOST LIKELY A PRE-ANALYTICAL ISSUE DUE TO MIS-SAMPLING CAUSED BY POOR SAMPLE QUALITY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ISE INDIRECT NA, K, CI FOR GEN.2 SODIUM AND POTASSIUM RESULTS FOR ONE PATIENT. THE INITIAL SODIUM RESULT WAS 72 MMOL/L AND THE INITIAL POTASSIUM RESULT WAS 3.6 MMOL/L. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. BECAUSE OF THE VERY LOW SODIUM RESULT, THE PHYSICIAN COMPLAINED AND THE SAMPLE WAS INVESTIGATED IN THE LABORATORY. A CLOT WAS FOUND IN THE SAMPLE AND AFTER REMOVING THE CLOT, THE SAMPLE WAS REPEATED. THE REPEAT SODIUM RESULTS WERE 54 MMOL/L, 72 MMOL/L, AND 138 MMOL/L. THE REPEAT POTASSIUM RESULT WAS 7.1 MMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT WAS 187403 WITH AN EXPIRATION DATE OF 08/28/2016. THE POTASSIUM ELECTRODE LOT WAS 212275 WITH AN EXPIRATION DATE OF 08/28/2016. THE FIELD SERVICE REPRESENTATIVE PERFORMED MAINTENANCE AND REPLACED THE ISE HOSE SET. TESTS WERE PERFORMED TO VERIFY THE PROPER FUNCTION OF THE DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681796 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO GENTAMYCIN