BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 12480576 · Received September 16, 2021

    Report

    Report Number
    1319808-2021-00015
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 16, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY ASSIGNABLE CAUSE FOR THE EVENT IS A CALIBRATION TO CALIBRATION BIAS ALONG WITH A GEN TO GEN BIAS BETWEEN GEN 29 AND GEN 30 REAGENT. IT IS LIKELY THE GEN 30 CALIBRATION IS AT THE LOWER END OF ACCEPTABLE RESPONSES WHILE THE GEN 29 CALIBRATION IS AT THE HIGHER END OF ACCEPTABLE RESPONSES. HISTORICAL QUALITY CONTROL RESULTS USING VITROS TDM PV FLUIDS OBTAINED FROM BOTH VITROS GEN 29 AND GEN 30 REAGENT WERE WITHIN EXPECTED RANGES, INDICATING BOTH VITROS GEN 30 AND GEN 29 REAGENT WAS PERFORMING AS INTENDED. AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS PATIENT CORRELATION SAMPLES, PROFICIENCY SAMPLE AND VITROS QUALITY CONTROL SAMPLES ALL EXHIBITED A SIMILAR NEGATIVE BIAS USING VITROS VALP GEN 30 REAGENT WHEN COMPARED TO VITROS VALP GEN 29 REAGENT. HOWEVER, SINCE DIAGNOSTIC PRECISION TESTING TO ASSESS THE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM WAS NOT PERFORMED, AN INSTRUMENT RELATED ISSUE CANNOT BE COMPLETELY RULE OUT AS CONTRIBUTING TO THE EVENT. IMPROPER SAMPLE HANDLING DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CORRELATION SAMPLES WERE TESTED CONCURRENTLY ON BOTH THE VITROS VALP REAGENT GENS. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS VALP PATIENT SAMPLE RESULT WAS OBTAINED USING VITROS VALP REAGENT LOT 2511-30-8784 (GEN 30) WHEN COMPARED TO RESULTS OBTAINED FROM THE SAME SAMPLES USING VITROS VALP REAGENT LOT 2511-29-8692 (GEN 29). PATIENT CORRELATION SAMPLE 2 RESULT OF 37.7 G/ML VS. THE EXPECTED VALUE OF 47.9 G/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VALP RESULT OBTAINED FROM PATIENT CORRELATION SAMPLE 2 GEN 30 WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376805 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-30-8784

    Patients

    Seq Age Sex Outcome Treatment
    1