BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS PRO ISE ANALYTICAL UNIT

    MDR report key: 20483318 · Received October 18, 2024

    Report

    Report Number
    1823260-2024-03018
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER IS ABS62. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DETERMINED THAT AN MTV VALVE FAILURE HAD CAUSED THE EVENT. THE FSE REPLACED THE VALVE FOR THE ION-SELECTIVE ELECTRODE (ISE) SYRINGE, STILETTE SIPPER NOZZLE, STILETTE ISE AND DILUENT (DIL) NOZZLES, DECONTAMINATED THE VACUUM NOZZLE, CLEANED THE DILUTION VESSEL AND WASTE LINE, PERFORMED SIPPER FLOW PATH DECONTAMINATION AND REPLACED ALL SYRINGE SEALS AND SIPPER TUBINGS. HE PERFORMED A 5-PATIENT COMPARISON/CROSS-CHECK TEST WITH THE TWO ANALYZERS, PRECISION CHECK, CALIBRATION, QC, AND ISE CHECK WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MEDWATCH, THE SECOND LINE OF H11 ADDITIONAL NARRATIVE SHOULD HAVE BEEN: "THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DETERMINED THAT A VALVE FAILURE HAD CAUSED THE EVENT." INSTEAD OF: "THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DETERMINED THAT AN MTV VALVE FAILURE HAD CAUSED THE EVENT." THE INVESTIGATION REVIEWED THE CALIBRATION PERFORMED AND QC DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE; THE TRACE HAD A "SAMPLE PROBE: ABNORMAL ASPIRATION" ALARM. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLY HIGH NA ELECTRODE RESULTS FROM TEN PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE TWO PATIENT SAMPLES WITH DISCREPANT RESULTS: SAMPLE 1: THE INITIAL RESULT FROM THE ANALYZER WAS 145.1 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS PRO ISE ANALYZER WAS 138.2 MMOL/L. SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS 155.1 MMOL/L. THE REPEAT RESULT FROM ANOTHER COBAS PRO ISE ANALYZER WAS 147.0 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND COMPLAINTS FROM THE PROVIDER PROMPTED THE PATIENT SAMPLE RERUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218920 COBAS PRO ISE ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown