BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS K+ SLIDES

    MDR report key: 4782077 · Received May 19, 2015

    Report

    Report Number
    1319809-2015-00075
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS K+ RESULT WAS OBTAINED FROM A SINGLE NON-VITROS BIORAD L1 QUALITY CONTROL FLUID USING VITROS K+ REAGENT PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, A PRE-ANALYTICAL SAMPLE MIX UP CANNOT BE RULED AS A CONTRIBUTING FACTOR. THE INVESTIGATION WAS ABLE TO RULE OUT A VITROS K+ REAGENT ISSUE OR VITROS INSTRUMENT ISSUE AS POSSIBLE CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED OF A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS K+ RESULT OBTAINED FROM A SINGLE NON-VITROS BIORAD L1 QUALITY CONTROL FLUID USING VITROS K+ REAGENT PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 RESULT OF 4.67 MMOL/L VS. EXPECTED 2.62 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326373 VITROS CHEMISTRY PRODUCTS K+ SLIDES IN-VITRO DIAGNOSTIC CEM ORTHO-CLINICAL DIAGNOSTICS 4102-0929-0839

    Patients

    Seq Age Sex Outcome Treatment
    1