BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCT VALP REAGENT

    MDR report key: 1017610 · Received March 12, 2008

    Report

    Report Number
    1319808-2008-00069
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE LAB OPERATOR WAS FOLLOWING THE LAB'S REAGENT PACK HANDLING PROTOCOL. A DEFINITIVE ROOT CAUSE OF THE BIASED VALP QC RESULTS COULD NOT BE DETERMINED, HOWEVER, IT IS MOST LIKELY ASSOCIATED WITH USER ERROR RELATED TO INCONSISTENT REAGENT PACK HANDLING. ACCEPTABLE PERFORMANCE HAS BEEN MAINTAINED FOLLOWING RE-ENFORCEMENT OF REAGENT PACK HANDLING PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED VALP QC RESULTS ON THE 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. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCT VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-11-7809

    Patients

    Seq Age Sex Outcome Treatment
    1