BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2132138 · Received June 17, 2011

    Report

    Report Number
    1319681-2011-00136
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT HIGHER THAN EXPECTED VALP QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5,1 FS ANALYZER. THE CUSTOMER PERFORMED "AS NEEDED" MAINTENANCE BY REPLACING THE PHOTOMETER LAMP. PERFORMANCE TESTING FOLLOWING LAMP REPLACEMENT VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. THE VITROS VALP REAGENT DID NOT MALFUNCTION. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS (TDM PV II QC RESULT = 88.0 UG/ML VS. EXPECTED RESULT = 72.1 UG/ML; MAS LEVEL 1 = 38.6 UG/ML VS. EXPECTED RESULT = 26.4 UG/ML) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENTS WERE TO RECUR WITH PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBER (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