BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2429481 · Received January 26, 2012

    Report

    Report Number
    1823260-2012-00543
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 26, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER DISCOVERED THE ACTIVATOR WAS EMPTY WHICH SHE BELIEVED WAS THE CAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    THE USER NOTICED LOW ANION GAPS FOR PATIENT SAMPLES AND FOUND QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FOR TWO PATIENT SAMPLES. OF THE DATA PROVIDED, THE SODIUM AND CHLORIDE RESULTS FOR ONE PATIENT SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL SODIUM RESULT WAS 133 MMOL/L AND THE INITIAL CHLORIDE RESULT WAS 101MMOL/L WHICH WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE SODIUM RESULT WAS 138 MMOL/L AND THE CHLORIDE RESULT WAS 104 MMOL/L. THE USER THEN RAN PRECISION TESTING ON THE PATIENT SAMPLE. THE SODIUM RESULTS WERE 137, 134, 139, 134, 129, 130, 133, 130 AND 129 MMOL/L. THE CHLORIDE RESULTS WERE 102, 99, 103, 99, 96, 97, 99, 98 AND 96 MMOL/L. THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULTS REPORTED AND THE USER SENT A CORRECTED REPORT WITH THE REPEAT RESULTS. THE SODIUM ELECTRODE LOT NUMBER WAS 21511250 WITH AN EXPIRATION DATE OF 12/30/2011. THE CHLORIDE ELECTRODE LOT NUMBER AND EXPIRATION DATE WAS NOT PROVIDED. THE USER DISCOVERED THE ACTIVATOR WAS EMPTY WHICH SHE BELIEVED WAS THE CAUSE OF THE ISSUE. SHE REPLACED THE ACTIVATOR AND REPEATED THE PRECISION TESTING USING A DIFFERENT SAMPLE AND ALL SODIUM RESULTS AGREED WITHIN 2 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1