BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE CHLORIDE CL/ISE

    MDR report key: 7515033 · Received May 15, 2018

    Report

    Report Number
    1823260-2018-01505
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 15, 2018
    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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE THE EXPIRATION DATE IS PROVIDED AS "INSTALL BEFORE (B)(6) 2018." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE ISE INDIRECT CL FOR GEN 2 RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS INTEGRA 400 PLUS. THE INITIAL CHLORIDE RESULT WAS 82 MMOL/L. THE CUSTOMER STATED THAT FOLLOWING THE INITIAL ERRONEOUS RESULT THERE WERE MULTIPLE ANALYZER ALARMS. THE REPEAT CHLORIDE RESULTS WERE 110 MMOL/L WITH A DATA FLAG. THE CUSTOMER REPEATED THE CHLORIDE TESTING AFTER A NEW SUCCESSFUL CALIBRATION AND GOT A RESULT OF 106 MMOL/L. THE CUSTOMER STATED THAT THEY DID NOT REPEAT THE POTASSIUM AND SODIUM TESTING BECAUSE THE CUSTOMER BELIEVED THE ORIGINAL RESULTS WERE ACCEPTABLE. THE ERRONEOUS RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY. THE CHLORIDE RESULT OF 106 MMOL/L WAS DEEMED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. THE INTEGRA 400+ SERIAL NUMBER WAS (B)(4). ON (B)(6) 2018 THE CUSTOMER TRIED CALIBRATING THE ISE'S MULTIPLE BUT THE CHLORIDE CALIBRATION KEPT FAILING. THE CUSTOMER HAD TO INSTALL A PREVIOUS CHLORIDE ELECTRODE OF THE SAME LOT TO GE A SUCCESSFUL CALIBRATION AND QC RESULTS. THE CUSTOMER DECLINED TO HAVE SERVICE DISPATCHED AND STATED THAT THEY HAVE NOT HAD ANY FURTHER ISSUES. FURTHER INVESTIGATION DETERMINED THAT CALIBRATION AND QC RESULTS PRIOR TO THE EVENT WERE ACCEPTABLE. IT WAS DETERMINED THAT THE ROOT CAUSE MAY BE RELATED TO THE GLUE THAT IS USED TO FIX THE MEMBRANE TO THE ELECTRODE HOUSING WHICH CAN CAUSE THE MEMBRANES TO NOT BE PROPERLY FIXED AND TIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356229 ELECTRODE CHLORIDE CL/ISE ELECTRODE, ION-SPECIFIC, CHLORIDE CGZ ROCHE DIAGNOSTICS NA 21574847

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR