BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9180 ELECTROLYTE ANALYZER

    MDR report key: 20212901 · Received September 13, 2024

    Report

    Report Number
    1823260-2024-02656
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    UDI-DI
    04015630031832
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER WAS 31241447 WITH AN INSTALL BEFORE DATE OF 06-SEP-2024. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CALCIUM (CA2+) RESULT FROM THE ELECTROLYTE ANALYZER W/O STARTERKIT 9180. THE INITIAL RESULT WAS 1.96 MMOL/L. THE REPEAT RESULT FROM A GEM ANALYZER WAS 1.17 MMOL/L. THIS RESULT WAS BELIEVED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113869 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown