BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE (DOUBLE)

    MDR report key: 20677255 · Received November 13, 2024

    Report

    Report Number
    1823260-2024-03299
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 20, 2024
    Report Date
    February 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. QC WAS ACCEPTABLE ON THE DAY OF THE EVENT. THE FSE PERFORMED THE FOLLOWING ACTIONS: REPLACED THE SOLENOID VALVE CHANGED THE SUCTION HOSES OF THE BOTTLES AND THEIR FILTERS RINSED, PRIMED, DID AN ISE CHECK, AND REPLACED THE ISE2 REAGENT CLEANED THE CUP, REPLACED THE VACUUM AND SIPPER NOZZLE, CHANGED THE SIPPER'S HOSE AND THE O-RINGS OF THE BLOCK, TREATED THE SIPPER LINE, FLUSHED THE REFERENCE SOLUTION TUBE LINE, AND REPLACED THE REFERENCE ELECTRODE. HE DID AN ISE CHECK AND IT WAS SUCCESSFUL. CLEANED THE CUP AND NOZZLES, CHANGED THE NEEDLE, AND RAISED THE GEAR PUMP PRESSURE TO THE RIGHT LEVEL. DID AN ISE CHECK AND IT SHOWED INSTABILITY. HE CORRECTED THE POSITION OF THE DILUENT NOZZLE AND REROUTED THE VACUUM LINE. HE NOTICED THAT THE OPERATION OF THE VACUUM NOZZLE WAS A BIT STRAINED AND NOT WORKING AT FULL POWER. HE THEN PERFORMED AN OPERATION MECHANISM CHECK, REAGENT PRIME, AND ISE CHECK. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR 2 ADDITIONAL PATIENTS' SAMPLES TESTED ON (B)(6) 2024: SAMPLE 22: INITIAL RESULT: 114 MMOL/L. REPEAT RESULT: 121.4 MMOL/L. SAMPLE 23: INITIAL RESULT: 119.3 MMOL/L. REPEAT RESULT: 128 MMOL/L. THE SAMPLES WERE REPEATED ON ANOTHER COBAS ISE (ISE3/ISE4). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ANALYSIS OF THE PROVIDED PICTURES SHOWED THAT >25% OF ALL SAMPLES SHOWED A FILM OF PARTICLES OF UNKNOWN ORIGIN ON THE SURFACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTIC'S ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 23 PATIENTS' SAMPLES TESTED ON A COBAS 8000 COBAS ISE MODULE (ISE2) WHEN COMPARED TO A DIFFERENT COBAS ISE MODULE (ISE1/ISE3/ISE4). RESULTS FOR THE SODIUM (NA) TEST WERE AFFECTED. OUT OF THE ALLEGED 23 PATIENTS' SAMPLES, RESULTS FOR 22 PATIENTS' SAMPLES WERE PROVIDED AND 21 OUT OF THOSE WERE DISCREPANT. SAMPLE 1: INITIAL RESULT: 132.5 MMOL/L. REPEAT RESULT: 140.2 MMOL/L. SAMPLE 1 WAS A PLASMA SAMPLE. SAMPLE 2: INITIAL RESULT: 133.4 MMOL/L. REPEAT RESULT: 139.7 MMOL/L. SAMPLE 3: INITIAL RESULT: 134.8 MMOL/L. REPEAT RESULT: 139.9 MMOL/L. SAMPLE 4: INITIAL RESULT: 130.7 MMOL/L. REPEAT RESULT: 137.2 MMOL/L. SAMPLE 5: INITIAL RESULT: 134.3 MMOL/L. REPEAT RESULT: 140.2 MMOL/L. SAMPLE 6: INITIAL RESULT: 129.4 MMOL/L. REPEAT RESULT: 136.2 MMOL/L. SAMPLE 7: INITIAL RESULT: 126.1 MMOL/L. REPEAT RESULT: 132.8 MMOL/L. SAMPLE 8: INITIAL RESULT: 128.3 MMOL/L. REPEAT RESULT: 135.7 MMOL/L. SAMPLE 9: INITIAL RESULT: 127.7 MMOL/L. REPEAT RESULT: 136.2 MMOL/L. SAMPLE 10: INITIAL RESULT: 115.4 MMOL/L. REPEAT RESULT: 120.5 MMOL/L. SAMPLE 11: INITIAL RESULT: 131.7 MMOL/L. REPEAT RESULT: 139.8 MMOL/L. SAMPLE 12: INITIAL RESULT: 131.3 MMOL/L. REPEAT RESULT: 138.3 MMOL/L. SAMPLE 13: INITIAL RESULT: 131.1 MMOL/L. REPEAT RESULT: 140.1 MMOL/L. SAMPLE 14: INITIAL RESULT: 132.6 MMOL/L. REPEAT RESULT: 141.4 MMOL/L. SAMPLE 15: INITIAL RESULT: 126.7 MMOL/L. REPEAT RESULT: 136.1 MMOL/L. SAMPLE 16: INITIAL RESULT: 127.1 MMOL/L. REPEAT RESULT: 136.3 MMOL/L. SAMPLE 17: INITIAL RESULT: 129.4 MMOL/L. REPEAT RESULT: 138.4 MMOL/L. SAMPLE 18: INITIAL RESULT: 134.6 MMOL/L. REPEAT RESULT: 144.9 MMOL/L. SAMPLE 19: INITIAL RESULT: 127.5 MMOL/L. REPEAT RESULT: 137.8 MMOL/L. SAMPLE 20: INITIAL RESULT: 123.6 MMOL/L. REPEAT RESULT: 133.2 MMOL/L. SAMPLE 21: INITIAL RESULT: 133.1 MMOL/L. REPEAT RESULT: 143.8 MMOL/L. ALL THE SAMPLES WERE REPEATED ON ANOTHER COBAS ISE (ISE1/ISE3/ISE4). THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432105 COBAS 8000 COBAS ISE MODULE (DOUBLE) CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown