BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK

    MDR report key: 1222832 · Received November 6, 2008

    Report

    Report Number
    1319808-2008-00332
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD FIELD SERVICE INVESTIGATED AND FOUND NO EVIDENCE TO SUGGEST THAT THE VITROS 5, 1 FS SYSTEM WAS NOT OPERATING AS INTENDED. THE ROOT CAUSE OF THE BIASED VALP QC RESULTS IS UNKNOWN; HOWEVER, REAGENT PACK-TO-PACK VARIABILITY CANNOT BE RULED OUT. THE INVESTIGATION DETERMINED THAT THE CUSTOMER PROCESSES A VERY LOW NUMBER OF VALP ASSAYS. REAGENT PACK HANDLING WAS REVIEWED WITH THE CUSTOMER. THE CUSTOMER HAS BEEN ABLE TO MAINTAIN ACCEPTABLE PERFORMANCE FOLLOWING THE IMPLEMENTATION OF A CONSISTENT REAGENT PACK HANDLING PROTOCOL.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED VITROS VALP QC RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-11-8320

    Patients

    Seq Age Sex Outcome Treatment
    1