BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 18282357 · Received December 7, 2023

    Report

    Report Number
    1823260-2023-03886
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 14, 2023
    Report Date
    January 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336158876
    PMA / PMN Number
    K191899
    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 CUSTOMER STATED THAT THE QC WAS OUT OF RANGE AT THE TIME OF THE EVENT. ON THE FIELD SERVICE ENGINEER'S (FSE) FIRST SERVICE VISIT, THE ANALYZER WAS INSPECTED AND NO HARDWARE ISSUES WERE FOUND. THE FSE STATED THAT THE CUSTOMER WAS INCORRECTLY READING THE CROSS-CHECK. THE FSE RECALIBRATED, RAN QC, AND REVIEWED PATIENT CROSS-CHECKS WITH THE CUSTOMER. THE ISSUE WAS NOT RESOLVED. ON THE FSE'S SECOND SERVICE VISIT, HE DETERMINED THE EVENT WAS CAUSED BY SOLENOID VALVES THAT NEEDED TO BE REPLACED AND AN ANALYZER KIT THAT HAD TO BE INSTALLED. THE FSE THEN CLEANED THE REAGENT FLOW PATH, SAMPLE TUBING, NOZZLES, AND SEALS. HE INSTALLED A KIT AND CLEANED DRIED SPILLAGE INSIDE THE ION-SELECTIVE ELECTRODE (ISE) CABINET. HE WAS UNABLE TO CALIBRATE THE ASSAY. HE THEN CHECKED AND CLEANED THE SEALS AND NOTED THE SAMPLE SYRINGE WAS DAMP WITH SALTY RESIDUE. ON THE FSE'S THIRD SERVICE VISIT, HE INSTALLED AND CONDITIONED THE KIT AND PERFORMED CALIBRATIONS WITH SUCCESSFUL RESULTS. HE CLEANED THE LEAK RESIDUES AND PERFORMED CROSS-CHECKS WITH MIXED RESULTS. HE FOUND A LEAK IN SOME OF THE SOLENOID VALVES (SV). HE THEN REPLACED THE SV AND NOTED THAT CROSS-CHECK RESULTS IMPROVED. ON THE FSE'S FOURTH SERVICE VISIT, HE NOTED THAT CROSS-CHECKS WERE ROUTINELY FAILING AND AN ADDITIONAL CROSS-CHECK GAVE POOR RESULTS. HE AGAIN CHECKED FOR LEAKS, ADJUSTED THE SAMPLE PROBE, AND REPLACED MORE SOLENOID VALVES. THE CUSTOMER PERFORMED CALIBRATIONS AND QCS WITH ACCEPTABLE RESULTS. THE FSE VERIFIED THAT THE CUSTOMER'S CROSS-CHECKS WERE CONSISTENT BETWEEN ANALYZERS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER STATED THAT THE QC WAS OUT OF RANGE AFTER A REPAIR VISIT PROMPTING THEM TO PERFORM A COMPARISON STUDY WITH ANOTHER COBAS PRO ISE ANALYTICAL UNIT. THEY FOUND THE SODIUM RESULTS WERE RUNNING HIGH ON THE REPORTED ANALYZER. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 1: THE INITIAL RESULT FROM THE ANALYZER WAS 150 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 141 MMOL/L. SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS 150 MMOL/L. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 142 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759019 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336158876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown