BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7707381 · Received July 20, 2018

    Report

    Report Number
    1319808-2018-00021
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 19, 2018
    Report Date
    January 3, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUR PRELIMINARY INVESTIGATION DETERMINED THAT UNDETECTED VARIABILITY IN THE RELEASE PROCESS CAUSED A NEGATIVE BIAS. WE HAVE IMPLEMENTED INTERIM CORRECTIVE ACTIONS TO HELP PREVENT FUTURE OCCURRENCES. THE FDA¿S NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON 12 DECEMBER 2018. PLEASE REFER TO REPORT #1319808-12/12/2018-001-C.

    Description of Event or Problem · 0

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED WHEN USING VITROS VALP REAGENT LOT 2511-25-6393 ON A VITROS 4600 CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE FOR THIS EVENT. BASED ON QUALITY CONTROL PERFORMANCE ON AN ALTERNATE INSTRUMENT, THE REAGENT IS PERFORMING AS EXPECTED. THEREFORE, THE REAGENT IS NOT LIKELY TO BE A CONTRIBUTING FACTOR. THE INSTRUMENT PERFORMANCE WAS NOT VERIFIED WITH A WITHIN RUN MARKER PERFORMANCE TEST. ALTHOUGH THERE IS NO INDICATION THE INSTRUMENT MALFUNCTIONED, THE INSTRUMENT CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR. ADDITIONALLY, AN ISSUE RELATED TO THE HANDLING OF THE TDM FLUIDS OR A SUB-OPTIMAL CALIBRATION EVENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT THE ASSIGNABLE CAUSE IS UNKNOWN. THE MDR IS BEING SUBMITTED AFTER THE 30 DAY REPORTING DATE DUE TO A TECHNICAL ISSUE WITH ORTHO¿S MDR REPORTING SYSTEM. ORTHO WAS UNABLE TO ELECTRONICALLY SUBMIT MDR'S FROM 5 JULY 2018 ¿ 19 JULY 2018.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WHEN USING VITROS TDM CONTROLS ON A VITROS 4600 CHEMISTRY SYSTEM. REAGENT LOT 2511-25-6393; VITROS TDM PERFORMANCE VERIFIER II (LOT N5702) VALP RESULT 53.09 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 68.9 UG/ML. VITROS TDM PERFORMANCE VERIFIER III (LOT T5896) VALP RESULT 91.27 UG/ML VERSUS THE EXPECTED VITROS VALP RESULT 115.6 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 CUSTOMER DID NOT PROCESS PATIENT SAMPLES DUE TO THE UNACCEPTABLE VALP QUALITY CONTROL RESULTS. HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547886 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-6393

    Patients

    Seq Age Sex Outcome Treatment
    1