BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 20905968 · Received December 11, 2024

    Report

    Report Number
    1823260-2024-03621
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) PERFORMED TWO SITE VISITS. DURING THE INITIAL VISIT, THE FSE USED THE ISE CLEANING KIT, CLEANED THE DRAIN, AND DILUTION CUP, AND CONFIRMED THE REACTIVE PRIMING AND ELECTRODE CONTROLS WERE OKAY. DURING THE SECOND VISIT, THE FSE INSTALLED THE ISE KIT MODIFICATION KIT, REPLACED THE VACUUM NOZZLE, AND VALIDATED THE TECHNICAL AND ANALYTICAL T1, T3, AND A1. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PROVIDED CALIBRATION, QC, ALARM, AND PRE-ANALYTICAL DATA DID NOT SHOW ANY ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE WITH THE K ELECTRODE ON A COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7.5MMOL/L. THE REPEAT RESULTS WERE 4.94 MMOL/L AND 4.85 MMOL/L, RESPECTIVELY. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745139 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown