BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORIDE ELECTRODE

    MDR report key: 14600728 · Received June 6, 2022

    Report

    Report Number
    1823260-2022-01605
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 17, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGZ
    UDI-DI
    08430215015353
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER DETERMINED THE ISSUE WAS CAUSED BY A DEFECTIVE CHLORIDE ELECTRODE. THE ANALYZER WAS CHECKED. THE ELECTRODE WAS REPLACED BY THE CUSTOMER AND THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 0

    UPON CUSTOMER INSPECTION OF THE AFFECTED ELECTRODE, THE CUSTOMER STATED THEY SAW SOMETHING INSIDE THE ELECTRODE THAT LOOKED LIKE FUNGUS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE CHLORIDE ELECTRODE ON A COBAS INTEGRA 400 PLUS (SERIAL NUMBER (B)(4)). THE SAMPLE INITIALLY RESULTED IN A CHLORIDE VALUE OF 142 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 115 MMOL/L. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186266 CHLORIDE ELECTRODE ELECTRODE, ION-SPECIFIC, CHLORIDE CGZ ROCHE DIAGNOSTICS NA 21520466 08430215015353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown