BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE (DOUBLE)

    MDR report key: 19529151 · Received June 13, 2024

    Report

    Report Number
    1823260-2024-01759
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER WAS NOT ABLE TO DETERMINE A CAUSE. HE CLEANED AND CHECKED THE ELECTRODE BLOCK AND PROBE/NOZZLE ALIGNMENTS, CHECKED FOR PROPER REAGENT DISPENSE AND VACUUM EVACUATION OF THE DILUTION VESSEL, AND CHECKED THE SYRINGES AND TUBING. HE CLEANED/FLUSHED THE SIPPER FLOW PATH, REPLACED THE ISE BASE SOLENOID VALVES, AND REPLACED THE VACUUM SOLENOID VALVE. HE REPLACED THE SIPPER AND VACUUM NOZZLES AND TUBING, REPLACED THE VACUUM NOZZLE LINEAR SOLENOID, AND REPLACED AND ADJUSTED THE DILUTION NOZZLE. HE PERFORMED ISE REAGENT PRIMES, ISE CHECKS, AND ISE PRECISION CHECKS WHICH WERE SUCCESSFUL. THE CUSTOMER RAN ISE CALIBRATION AND QC AND ALL RECOVERED WITHIN THE GUIDELINES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER WAS U5535 WITH AN EXPIRATION DATE OF 19-JAN-2025. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ISE SODIUM RESULTS FROM THE COBAS 8000 COBAS ISE MODULE. THE SAMPLES WERE REPEATED ON VARIOUS ISE MODULES. THE CUSTOMER COULD NOT PROVIDE SPECIFIC ANALYZERS. "SAMPLE 3" INITIAL RESULT WAS 131 MMOL/L AND THE REPEAT RESULT WAS 138 MMOL/L. ON (B)(6) 2024, SAMPLE (B)(6) INITIAL RESULT WAS 125 AND THE REPEAT RESULTS WERE 131, 131, 131, AND 125 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 125 MMOL/L AND THE REPEAT RESULTS WERE 134 AND 133 MMOL/L. SAMPLE (B)(6) INITIAL RESULT WAS 124 MMOL/L AND THE REPEAT RESULTS WERE 130, 130, 130, AND 126 MMOL/L. THE REPEAT RESULTS WERE BELIEVED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184403 COBAS 8000 COBAS ISE MODULE (DOUBLE) CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown