BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 3037226 · Received April 5, 2013

    Report

    Report Number
    1319808-2013-00024
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE DURING A LOT TO LOT CORRELATION STUDY ON A VITROS 5,1 FS CHEMISTRY SYSTEM. ADDITIONALLY, A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP RESULT WAS OBTAINED FROM A DIFFERENT PATIENT SAMPLE USING A VITROS 5,1 FS CHEMISTRY SYSTEM WHEN COMPARED TO A NON-VITROS METHOD DURING A CORRELATION STUDY. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE AFFECTED RESULT FROM THE LOT TO LOT CORRELATION STUDY. HOWEVER, SAMPLE HANDLING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR FOR THE INITIAL CORRELATION STUDY. THE ROOT CAUSE FOR THE AFFECTED RESULT FROM THE VITROS VS. NON-VITROS CORRELATION STUDY COULD NOT BE DETERMINED. NO FURTHER CONCLUSION CAN BE REACHED AT THIS TIME AS THE CUSTOMER HAS DECLINED TO CONTINUE THE INVESTIGATION. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT WITH RESPECT TO BOTH THE CORRELATION STUDIES.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP RESULT FROM A SINGLE PATIENT SAMPLE DURING A LOT TO LOT CORRELATION STUDY ON A VITROS 5,1 FS CHEMISTRY SYSTEM. ADDITIONALLY, A NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS VALP RESULT WAS OBTAINED FROM A DIFFERENT PATIENT SAMPLE USING A VITROS 5,1 FS CHEMISTRY SYSTEM WHEN COMPARED TO A NON-VITROS METHOD DURING A CORRELATION STUDY. THE FOLLOWING RESULTS WERE OBTAINED: VITROS VALP LOT 2511-21-2721 VS. VITROS VALP LOT 2511-20-2483 PATIENT SAMPLE 1 = 83.5 VS. AN EXPECTED RESULT = 69.0 UG/ML; VITROS VS. NON-VITROS METHOD: PATIENT SAMPLE 2 = 63 VS. AN EXPECTED RESULT = 51 UG/ML; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN. HOWEVER, THE AFFECTED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AS THESE WERE PART OF A CORRELATION STUDY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141571 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-21-2721

    Patients

    Seq Age Sex Outcome Treatment
    1