BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 3024159 · Received March 27, 2013

    Report

    Report Number
    1319808-2013-00020
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 27, 2013
    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

    THE INVESTIGATION DETERMINED THAT MULTIPLE, REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP PATIENT RESULTS WERE OBTAINED ON TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS DURING A CORRELATION STUDY. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A VITROS VALP REAGENT ISSUE CANNOT BE RULED OUT. IN ADDITION, THE POSSIBILITY THAT THE VITROS VALP GEN 18 PATIENT RESULTS WERE BIASED CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP PATIENT RESULTS ON TWO DIFFERENT VITROS 5,1 FS CHEMISTRY SYSTEMS DURING A CORRELATION STUDY. THE FOLLOWING RESULTS WERE OBTAINED: VALP GEN 21, LOT 2571 VS. VALP GEN 18, LOT 2164: 5,1 FS #1: PATIENT 1 = 44.9, 45.5 VS. AN EXPECTED RESULT = 33.9 UG/ML; PATIENT 2 = 89.6 VS. AN EXPECTED RESULT = 74.4 UG/ML; PATIENT 3 = 98.0 VS. AN EXPECTED RESULT = 75.7 UG/ML; 5,1 FS #2: PATIENT 1 = 46.6 VS. AN EXPECTED RESULT = 39.1 UG/ML; PATIENT 2= 92.0 VS. AN EXPECTED RESULT = 74.6 UG/ML; VALP GEN 21, LOT 2721 VS. VALP GEN 18, LOT 2164: 5,1 FS #1: PATIENT 1 = 52.2 VS. AN EXPECTED RESULT = 33.9 UG/ML; PATIENT 2 = 96.3 VS. AN EXPECTED RESULT = 74.4 UG/ML; PATIENT 3 = 100.2 VS. AN EXPECTED RESULT = 75.7 UG/ML; 5,1 FS #2: PATIENT 1 = 50.7 VS. AN EXPECTED RESULT = 33.9 UG/ML; PATIENT 2 = 93.1 VS. AN EXPECTED RESULT = 74.4 UG/ML; PATIENT 3 = 102.6 VS. AN EXPECTED RESULT = 75.7 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. THE AFFECTED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDRS 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
    126215 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-21-2571

    Patients

    Seq Age Sex Outcome Treatment
    1