BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 8946731 · Received August 29, 2019

    Report

    Report Number
    1319808-2019-00030
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM SEVERAL PATIENT SAMPLES WHEN USING VITROS VALP REAGENT LOT 2511-27-7043 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE VITROS 5600 INTEGRATED SYSTEM THAT PRODUCED THE HIGHER THAN EXPECTED RESULTS HAD NOT BEEN CALIBRATED SINCE MARCH OF 2019. AFTER A CALIBRATION EVENT WAS PERFORMED ON THE INSTRUMENT ON 01 AUGUST 2019, THE HISTORICAL QUALITY CONTROL RESULTS LOWERED CLOSER TO THE PEER MEAN DATA. ADDITIONALLY, AFTER THE CALIBRATION EVENT ON 01 AUGUST 2019, SOME OF THE PATIENT SAMPLES WERE REPEATED ON THE INSTRUMENT AND THOSE RESULTS WERE CONCORDANT WITH THE RESULTS OF THE SAME SAMPLES TESTED ON AN ALTERNATE VITROS 5600 INTEGRATED SYSTEM. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS VALP LOT 2511-27-7043 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. PRIOR TO THE CALIBRATION EVENT ON 01 AUGUST 2019, THE CUSTOMER QUALITY CONTROL RESULTS WERE RUNNING HIGH COMPARED TO THE PEER DATA. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VALP REAGENT LOT 2511-27-7043. AS THE CUSTOMER DECLINED TO CONDUCT MARKER PRECISION TESTING ON THE VITROS 5600 INTEGRATED SYSTEM, AN ISSUE WITH THE INSTRUMENT COULD NOT BE ENTIRELY RULED OUT. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST AN ANALYZER ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS FROM SEVERAL PATIENT SAMPLES WHEN USING VITROS VALP REAGENT LOT 2511-27-7043 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 5 SAMPLE RESULT OF 39.7 UG/ML VERSUS THE EXPECTED RESULT OF 28.4 UG/ML. PATIENT 10 SAMPLE RESULT OF 130.8 UG/ML VERSUS THE EXPECTED RESULT OF 104.0 UG/ML. PATIENT 11 SAMPLE RESULT OF 105.8 UG/ML VERSUS THE EXPECTED RESULT OF 80.1 UG/ML. PATIENT 12 SAMPLE RESULT OF 91.0 UG/ML VERSUS THE EXPECTED RESULT OF 73.7 UG/ML. PATIENT 13 SAMPLE RESULT OF 76.3 UG/ML VERSUS THE EXPECTED RESULT OF 58.2 UG/ML. PATIENT 14 SAMPLE RESULT OF 66.6 UG/ML VERSUS THE EXPECTED RESULT OF 51.6 UG/ML. PATIENT 15 SAMPLE RESULT OF 51.8 UG/ML VERSUS THE EXPECTED RESULT OF 34.7 UG/ML. PATIENT 16 SAMPLE RESULT OF 41.0 UG/ML VERSUS THE EXPECTED RESULT OF 26.8 UG/ML. PATIENT 17 SAMPLE RESULT OF 28.7 UG/ML VERSUS THE EXPECTED RESULT OF 16.3 UG/ML. PATIENT B SAMPLE RESULT OF 101.6 UG/ML VERSUS THE EXPECTED RESULT OF 80.1 UG/ML. PATIENT C SAMPLE RESULT OF 89.4 UG/ML VERSUS THE EXPECTED RESULT OF 73.7 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS VALP RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM DUE TO THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742051 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-27-7043

    Patients

    Seq Age Sex Outcome Treatment
    1