BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE (DOUBLE)

    MDR report key: 20832308 · Received December 3, 2024

    Report

    Report Number
    1823260-2024-03502
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE CALIBRATION AND QC DATA. DATA DOES NOT COVER THE DATE OF THE EVENT. THE (B)(6) 2024 CALIBRATION RESULTS WERE WITHIN SPECIFICATIONS. THE QC RECOVERY PROVIDED WAS WITHIN SPECIFICATIONS. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER IS Y41. THE K ELECTRODE LOT NUMBER IS H91. THE CL ELECTRODE LOT NUMBER IS AQQ. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND COULD NOT DETERMINE THE EVENT'S CAUSE. HE CHECKED THE MODULE¿S OVERALL OPERATION AND FOUND NO ISSUES. HE LOADED NEW REAGENTS AND VERIFIED THE MODULE¿S PERFORMANCE WITH AN ION-SELECTIVE ELECTRODE CHECK, CALIBRATIONS, AND A PRECISION CHECK. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE NA ELECTRODE, CL ELECTRODE, AND K ELECTRODE RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS ISE MODULE (DOUBLE). THE INITIAL RESULTS DID NOT MATCH THE PATIENT HISTORY ON REVIEW PROMPTING THE RERUN OF THE PATIENT SAMPLE ON ANOTHER COBAS 8000 ISE MODULE. THE INITIAL NA RESULT FROM THE MODULE WAS 118 MMOL/L. THE REPEAT RESULT FROM THE OTHER COBAS 8000 ISE MODULE WAS 139 MMOL/L. THE INITIAL CL RESULT FROM THE MODULE WAS 126 MMOL/L. THE REPEAT RESULT FROM THE OTHER COBAS 8000 ISE MODULE WAS 99 MMOL/L. THE INITIAL K RESULT FROM THE MODULE WAS 3.3 MMOL/L. THE REPEAT RESULT FROM THE OTHER COBAS 8000 ISE MODULE WAS 4.0 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543139 COBAS 8000 COBAS ISE MODULE (DOUBLE) CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female