BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 4279091 · Received November 26, 2014

    Report

    Report Number
    1319809-2014-00063
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    October 7, 2014
    Report Date
    November 26, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE VITROS LPV FLUID USING VITROS AMON MICRO SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE THE MOST LIKELY ASSIGNABLE CAUSE; HOWEVER, A TRANSIENT INSTRUMENT OR REAGENT RELATED ISSUE CANNOT BE RULED OUT. THE CUSTOMER¿S FLUID AND SLIDE HANDLING PROTOCOL WAS NOT QUESTIONED, THEREFORE, IMPROPER FLUID OR SLIDE HANDLING PROTOCOL CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A REVIEW OF VITROS AMON QUALITY CONTROL RESULTS INDICATED THE CUSTOMER IS STILL EXPERIENCING VITROS AMON WITHIN-LAB IMPRECISION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A HIGHER THAN EXPECTED RESULT FROM A SINGLE VITROS LPV FLUID USING VITROS AMON MICROSLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS LPV RESULT OF 277.3 UMOL/L VS. EXPECTED RESULT OF 190.0 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT ERE TO RECUR UNDETECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768100 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1014-0234-3339

    Patients

    Seq Age Sex Outcome Treatment
    1