BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 6928092 · Received October 9, 2017

    Report

    Report Number
    1319808-2017-00021
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 3, 2017
    Report Date
    October 9, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM TESTING VITROS TDM PERFORMANCE VERIFIER QC MATERIAL SAMPLES PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-25-5727 ON VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS PRE-ANALYTICAL SAMPLE HANDLING. THE PROPER PRE-ANALYTICAL FLUID HANDLING PROTOCOL WAS COMMUNICATED TO THE CUSTOMER (TO ALLOW THE FLUID MATERIAL TO EQUILIBRATE TO ROOM TEMPERATURE PRIOR TO TESTING), AND ONCE THE PROTOCOL ERRORS WERE ADDRESSED, THE ISSUE WAS RESOLVED. A VITROS VALP REAGENT AND A VITROS 5600 INSTRUMENT MALFUNCTION ARE NOT LIKELY CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED ORTHO TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS VALP RESULTS OBTAINED FROM TESTING VITROS TDM PERFORMANCE VERIFIERS ON A VITROS 5600 SYSTEM. VITROS TDM PVI (LOT B5000) VITROS VALP RESULTS 36.71, 11.36, AND 11.00 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 26.67 UG/ML. VITROS TDM PVII (LOT K5350) VITROS VALP RESULTS 82.46, 82.61, 84.88, 83.56, 40.28, AND 40.49 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 68.05 UG/ML. VITROS TDM PVIII (LOT D5002) VITROS VALP RESULTS 73.36 AND 73.80 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 113.14 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 HIGHER AND LOWER THAN EXPECTED VALP RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708234 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-5727

    Patients

    Seq Age Sex Outcome Treatment
    1