BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3931317 · Received July 14, 2014

    Report

    Report Number
    1823260-2014-05159
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SODIUM ELECTRODE LOT NUMBER WAS Z13.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED DATA, THE ISSUE WAS LIKELY CAUSED BY USAGE OF EVAPORATED STANDARDS DURING THE CALIBRATION.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FOR 43 PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON A COBAS C311 ANALYZER AT THE SITE. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT. THE INITIAL SODIUM RESULT WAS 132 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 141 MMOL/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE CHECKED THE ISE SYSTEM WHICH WAS OK. HE ADJUSTED THE SIPPER AND REAGENT PROBES AND CLEANED THE ELECTRODE BLOCK. THE CUSTOMER RAN CALIBRATION AND QC WHICH WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409130 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1