BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 6247987 · Received January 12, 2017

    Report

    Report Number
    1319809-2017-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    January 16, 2017
    Report Date
    January 12, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+, CREA, AND K+ RESULTS WERE OBTAINED FROM 3 DIFFERENT PATIENTS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. HOWEVER, BASED ON REPRODUCIBLE RESULTS OBTAINED FROM RETESTING, THE CUSTOMER CONCLUDED THAT THE VITROS RESULTS INITIALLY OBTAINED FROM EACH SAMPLE WERE LIKELY DUE TO A PRE-ANALYTICAL SAMPLE RELATED ISSUE. THE PROTOCOL USED FOR PRE ANALYTICAL SAMPLE COLLECTION AND PROCESSING AT THE ALTERNATE SITE IS UNKNOWN, AND THEREFORE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. ALTHOUGH THERE WERE NO INDICATIONS OF AN INSTRUMENT MALFUNCTION, A WITHIN-RUN PRECISION MARKER TEST WAS NOT COMPLETED, AND THEREFORE, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. SINCE NO QUALITY CONTROL DATA WAS PROVIDED, THE PERFORMANCE OF THE AFFECTED ASSAYS IS UNKNOWN AND CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, AS THE RESULTS FOR THE PATIENT SAMPLES WERE REPRODUCIBLE UPON RETESTING THE SAME SAMPLES, IT IS UNLIKELY THE VITROS REAGENT LOTS IN USE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED, NON-REPRODUCIBLE VITROS NA+, CREA, AND K+ RESULTS OBTAINED FROM 3 DIFFERENT PATIENTS WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED TO THE PHYSICIAN, AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 1 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30868 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTIC KSG ORTHO-CLINICAL DIAGNOSTICS 4202-0958-5644

    Patients

    Seq Age Sex Outcome Treatment
    1