BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1930833 · Received December 16, 2010

    Report

    Report Number
    1319681-2010-00279
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT RESULTS OCCURRED ON CONTROL FLUIDS PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, A REAGENT OR AN ANALYZER ISSUE COULD NOT BE RULED OUT. PRE-SERVICE PRECISION TESTING WAS OUTSIDE OF OCD GUIDELINES FOR THIS VITROS 5,1 SYSTEM. AN OCD FIELD ENGINEER RETURNED THE SYSTEM TO EXPECTED OPERATION BY REPLACING THE IWF PUMP. POST-SERVICE PRECISION TESTING USING THE PHYT LOT IN USE, WAS OUTSIDE OF OCD GUIDELINES FOR THIS VITROS 5,1 FS SYSTEM , WHILE PRECISION TESTING WAS WITHIN OCD GUIDELINES ON AN ALTERNATE VITROS 5,1 FS SYSTEM. FURTHER INVESTIGATION OF THE PHYT SLIDES IN USE COULD NOT BE CONTINUED DUE TO LACK OF INVENTORY. AN ALTERNATE LOT OF PHYT WAS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THIS CUSTOMER OBSERVED IMPRECISE, NEGATIVELY BIASED PHENYTOIN RESULTS ON CONTROL FLUIDS USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION SHOULD THEY OCCUR ON PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1