BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 4046803 · Received August 29, 2014

    Report

    Report Number
    1319681-2014-00140
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM 3 DIFFERENT VITROS TDM PV QUALITY CONTROL FLUIDS USING VITROS VALP REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED EVENT, AS ACCEPTABLE PERFORMANCE WAS OBTAINED ON AN ALTERNATE VITROS 5,1 FS INSTRUMENT USING THE SAME LOT OF VITROS VALP REAGENT. ACCEPTABLE VITROS VALP REAGENT LOT 2511-22-3413 PERFORMANCE WAS OBTAINED WITH SERVICE /REPAIR ACTIONS TO THE INSTRUMENT FOLLOWED BY CALIBRATION OF THE VITROS VALP REAGENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM 3 DIFFERENT VITROS TDM PV QUALITY CONTROL FLUIDS USING VITROS VALP REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: TDM Y2955: VALP RESULT OF 40.57 UG/ML VS. THE EXPECTED RESULT OF 27.7 UG/ML. TDM A2956: VALP RESULTS OF 98.12, 96.03 UG/ML VS. THE EXPECTED RESULT OF 66.3 UG/ML. TDM B2957: VALP RESULTS OF >150.0, 148.7, 140.51 UG/ML VS. THE EXPECTED RESULT OF 112.8 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530476 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1