BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 ISE 1800 MODULE

    MDR report key: 13671894 · Received March 4, 2022

    Report

    Report Number
    1823260-2022-00586
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946341
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    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 ISE CHECK WAS REPORTED TO BE IN RANGE AND STABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER DID NOT FIND ANY ISSUES WITH THE GEAR PUMP HEAD (GPH), THE ADJUSTMENT AND THE VACUUM. HE PERFORMED MULTIPLE ION-SELECTIVE ELECTRODE (ISE) CHECKS. THE SAMPLE SYRINGE SEALS DID NOT INDICATE AN ISSUE. HE PERFORMED CALIBRATION AND MULTIPLE QCS WITH ACCEPTABLE RESULTS. A COMPARISON TEST BETWEEN LINES 1 AND 2 USING PATIENT SAMPLES WAS PERFORMED WITH ACCEPTABLE RESULTS. THE SAMPLE PROBE COVER SPRING WAS NOTED TO BE SLIGHTLY TIGHT. A NEW COVER AND SPRING FOR THE MODULE WERE PROVIDED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT GEN.2 NA RESULTS FOR TWO PATIENT SAMPLES TESTED ON A COBAS 8000 ISE MODULE (DOUBLE). IT WAS UNKNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE INITIALLY RUN IN LINE 1 OF THE ION-SELECTIVE ELECTRODE (ISE) MODULE AND WERE RERUN IN LINE 2 OF THE ISE MODULE. SAMPLE 1 HAD AN INITIAL RESULT FROM LINE 1 OF 121 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 128 MMOL/L. SAMPLE 2 HAD AN INITIAL RESULT FROM LINE 1 OF 123 MMOL/L. THE REPEAT RESULT FROM LINE 2 WAS 135 MMOL/L. THE ELECTRODE LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669583 COBAS 8000 ISE 1800 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 ISE NA 04015630946341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown