BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 10451512 · Received August 25, 2020

    Report

    Report Number
    1319808-2020-00032
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY REPORTED LOWER THAN EXPECTED VITROS VALP PATIENT SAMPLE RESULTS WERE OBTAINED USING VITROS VALP REAGENT LOT 2511-28-8096 WHEN COMPARED TO RESULTS OBTAINED FROM THE SAME SAMPLES USING VITROS VALP REAGENT LOT 2511-27-7325.THE INVESTIGATION DETERMINED THE RESULTS OBTAINED FROM VITROS VALP REGENT LOT 2511-28-8096 WERE ACTUALLY THE EXPECTED RESULTS, AND THE RESULTS OBTAINED FROM VITROS VALP REAGENT LOT 2511-27-7325 WERE HIGHER THAN EXPECTED. THE ASSIGNABLE CAUSE FOR THE EVENT IS UNKNOWN, HOWEVER, A REAGENT RELATED ISSUE OR A CALIBRATION ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HISTORICAL QUALITY CONTROL RESULTS OBTAINED FROM NON-VITROS UNASSAYED QUALITY CONTROLS WERE HIGHER THAN EXPECTED COMPARED TO THE PI MEANS, HOWEVER, NO PEER DATA WAS AVAILABLE TO DETERMINE IF THE RESULTS WERE COMPARABLE TO RESULTS OBTAINED FROM OTHER VITROS USERS. THE CALIBRATION DATA WAS NO LONGER AVAILABLE FOR REVIEW AS THE CALIBRATION EVENT OCCURRED >90 DAYS AGO, THEREFORE IT WAS NOT POSSIBLE TO DETERMINE IF THE CALIBRATION DATA WAS ATYPICAL. VITROS VALP REAGENT LOT 2511-27-7325 EXPIRED AND IS NO LONGER AVAILABLE FOR FURTHER INVESTIGATION. AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS WITHIN-RUN PERFORMANCE PRECISION TESTING WAS ACCEPTABLE USING AN ALTERNATE LOT OF REAGENT. IMPROPER SAMPLE HANDLING DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CORRELATION SAMPLES WERE STORED AS PER THE GUIDELINES INDICATED IN THE VITROS VALP INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SUPPORT CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED VITROS VALP RESULTS OBTAINED FROM VALP LOT 2511-27-7325 PATIENT SAMPLES WHEN COMPARED TO THE EXPECTED RESULTS OF VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-28-8096 AND VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-26-7728 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. CORRELATION SAMPLE 2 RESULT OF 579 UMOL/L VS. THE EXPECTED VALUE OF 482 UMOL/L. CORRELATION SAMPLE 3 RESULTS OF 467 UMOL/L VS. THE EXPECTED VALUE OF 367 UMOL/L. CORRELATION SAMPLE 4 RESULT OF 636 UMOL/L VS. THE EXPECTED VALUE OF 518 UMOL/L. CORRELATION SAMPLE 5 RESULTS OF 539 UMOL/L VS. THE EXPECTED VALUE OF 447 UMOL/L. CORRELATION SAMPLE 6 RESULT OF 383 UMOL/L VS. THE EXPECTED VALUE OF 302 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE GEN 28 VALP RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE GEN 27 RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916749 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-27-7325

    Patients

    Seq Age Sex Outcome Treatment
    1