BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9180 ELECTROLYTE ANALYZER

    MDR report key: 20110886 · Received August 30, 2024

    Report

    Report Number
    1823260-2024-02522
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 9, 2024
    Report Date
    January 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE EXPIRATION DATE WAS 27-SEP-2024. THE SAMPLES WERE SERUM SAMPLES. THE MAINTENANCE OF THE INSTRUMENT WAS LAST PERFORMED ON 20-OCT-2023 AND IT WAS UP TO DATE. THE CLEANING AND CONDITIONING WERE PERFORMED DAILY. THE FIELD SERVICE ENGINEER REPLACED THE MAIN HARNESS, QUAD-RING, AND O-RING. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER IS 31235147. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND CRYSTALLIZATION ON THE SNAP PACK RUBBER CONNECTOR AND THE ELECTRODE HOLDER/SAMPLE SENSOR AND ALSO FOUND BUBBLING IN THE PUMP TUBES AND A NICK IN THE RUBBER O-RING OF AN ELECTRODE. THE FSE CLEANED THE SYSTEM AND REPLACED THE NA ELECTRODE, A SYRINGE, THE HARNESS AND MAIN TUBING, A QUAD RING, AND AN ELECTRODE SEAL. THE FSE PERFORMED MECHANICAL AND PERFORMANCE CHECKS, CALIBRATION, AND QC SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 5 PATIENT SAMPLES ON A 9180 ELECTROLYTE ANALYZER. ON 09-AUG-2024, SAMPLE 1 HAD AN INITIAL RESULT OF 147 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 201 MMOL/L, 156 MMOL/L, 146 MMOL/L, 147 MMOL/L, AND 146 MMOL/L. ON 09-AUG-2024, SAMPLE 2 HAD AN INITIAL RESULT OF 132 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 108 MMOL/L, 130 MMOL/L, 127 MMOL/L, 117 MMOL/L, AND 130 MMOL/L. ON 09-AUG-2024, SAMPLE 3 HAD AN INITIAL RESULT OF 118 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 143 MMOL/L, 118 MMOL/L, 116 MMOL/L, 116 MMOL, AND 116 MMOL/L. THE CUSTOMER CHANGED THE SNAP PACK, REFERENCE ELECTRODE, AND ELECTRODE HOUSING PRIOR TO RUNNING THE FOLLOWING TWO SAMPLES. ON 19-AUG-2024, SAMPLE 4 HAD AN INITIAL RESULT OF 118 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 112 MMOL/L, 114 MMOL/L, 115 MMOL/L, 117 MMOL/L, 118 MMOL/L, AND 117 MMOL/L. ON 19-AUG-2024, SAMPLE 5 HAD AN INITIAL RESULT OF 120 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 118 MMOL/L, 114 MMOL/L, 118 MMOL/L, 118 MMOL/L, 118 MMOL/L, AND 118 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793602 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown