BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 2784047 · Received October 11, 2012

    Report

    Report Number
    1319808-2012-00032
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED VITROS VALP RESULTS WERE OBTAINED FROM MULTIPLE QUALITY CONTROL SAMPLES PROCESSED ON TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEM. ACCEPTABLE VITROS VALP PERFORMANCE HAS BEEN OBSERVED USING AN ALTERNATE REAGENT PACK FROM THE SAME LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS VALP REAGENT PACKS IN USE AT THE TIME OF THE EVENT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE UNEXPECTED VITROS VALP QUALITY CONTROL RESULTS USING TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS. 5,1 FS #1, QC FLUID BIORAD 1: 33.6 UG/ML VS. 22.93 UG/ML. 5,1 FS #1, QC FLUID BIORAD 2: 94.1 UG/ML, 94.1 UG/ML, 95.1 UG/ML, 59.9 UG/ML VS. 78.03 UG/ML. 5,1 FS #1, QC FLUID BIORAD 3: 98.9 UG/ML VS. 124.19 UG/ML. 5,1 FS #2, QC FLUID BIORAD 1: 31.0 UG/ML, 33.2 UG/ML, 34.9UG/ML VS. 19.42 UG/ML. 5,1 FS #2, QC FLUID BIORAD 2: 89.9 UG/ML, 92.1 UG/ML, 94.8 UG/ML, 103.4 UG/ML, 85.0 UG/ML VS. 70.17 UG/ML. 5,1 FS #2, QC FLUID BIORAD 3: 136.4 UG/ML, 138.0 UG/ML, 149.2 UG/ML VS. 111.72 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO RE-OCCUR UNDETECTED WITH PATIENT SAMPLES. PATIENT SAMPLES WERE NOT RUN WHILE THE QUALITY CONTROL RESULTS WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-18-2164

    Patients

    Seq Age Sex Outcome Treatment
    1