BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL ELECTRODE

    MDR report key: 14603803 · Received June 6, 2022

    Report

    Report Number
    1823260-2022-01631
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 13, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGZ
    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 INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS AN ISSUE WITH THE CHLORIDE ELECTRODE. HE CHECKED THE ISE FLOW PATH, CALIBRATION, AND QC. HE REPLACED THE CHLORIDE ELECTRODE. REPEATED ISE CALIBRATION AND QC WITH RESULTS WITHIN RANGE. SODIUM CALIBRATION WAS OK, WITH NO ALARMS. UPON REVIEW OF CONTROL DATA, SODIUM CONTROLS WERE OUTSIDE OF RANGE ON (B)(6) 2022 AND (B)(6) 2022. MULTIPLE SAMPLE PROBE ASPIRATION ALARMS OCCURRED ON THE DAY OF THE EVENT. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ISE INDIRECT GEN RESULTS FROM THE COBAS PRO ISE ANALYTICAL UNIT THAT WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE LATER CORRECTED. ONLY DATA FOR ONE SAMPLE THAT WAS NOT REPORTED OUTSIDE OF THE LABORATORY WAS PROVIDED. THE INITIAL SODIUM RESULT WAS 146 MMOL/L. AS THE QC RESULTS WERE HIGH, THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 138 MMOL/L, WHICH WAS BELIEVED TO BE CORRECT. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439112 CL ELECTRODE ELECTRODE, ION-SPECIFIC, CHLORIDE CGZ ROCHE DIAGNOSTICS NA ASKU
    366201 CL ELECTRODE ELECTRODE, ION-SPECIFIC, CHLORIDE CGZ ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Male