BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7583981 · Received June 8, 2018

    Report

    Report Number
    1319808-2018-00017
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 13, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED DURING A PATIENT CORRELATION WHEN USING VITROS VALP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE AN ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS VALP RESULTS. DIAGNOSTIC WITHIN RUN VITROS GENT AND VITROS DLDL PRECISION TESTS WERE WITHIN ORTHO GUIDELINES INDICATING THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED. THEREFORE, AN INSTRUMENT RELATED ISSUE IS NOT LIKELY A CONTRIBUTOR OF THE EVENT. THERE WERE NO HISTORICAL QUALITY CONTROL RESULTS TO CONFIRM THE PERFORMANCE OF VITROS VALP REAGENT LOT 2511-25-6393 PRIOR TO THE EVENT. THE CUSTOMER DID NOT PLACE THIS LOT INTO ROUTINE USE DUE TO BIASED LOW RESULTS FROM NON-VITROS BIORAD LEVEL 3 CONTROL FLUID WHEN COMPARED TO THE BIORAD PEER GROUP MEAN. HOWEVER, THE CUSTOMER DID PROCESS VITROS TDM PERFORMANCE VERIFIER FLUIDS DURING THE INVESTIGATION AND RESULTS WERE WITHIN THE VITROS CONTROL ASSAY SHEET RANGE OF MEANS, INDICATING ACCEPTABLE ACCURACY. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-25-6393. THE LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED DURING A PATIENT SAMPLE CORRELATION. THE PRE-ANALYTICAL HANDLING OF SAMPLES USED FOR THE PATIENT CORRELATION WAS UNKNOWN. ADDITIONAL PATIENT CORRELATIONS WERE PERFORMED WHICH GENERATED ACCEPTABLE VALP RESULTS. ALTHOUGH SAMPLE HANDLING AND/OR THE STABILITY OF THE SAMPLES IS THE LIKELY CAUSE OF THE LOWER THAN EXPECTED VITROS VALP RESULTS, WITHOUT ADDITIONAL INFORMATION REGARDING THE CORRELATION PROCEDURE THIS COULD NOT BE CONFIRMED.

    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

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED DURING A PATIENT CORRELATION WHEN USING VITROS VALP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 6 VITROS VALP = 41.9 UG/ML VERSUS EXPECTED VITROS VALP 55 UG/ML. PATIENT SAMPLE 9 VITROS VALP = 31.5 UG/ML VERSUS EXPECTED VITROS VALP 50 UG/ML. PATIENT SAMPLE 12 VITROS VALP = 65.6 UG/ML VERSUS EXPECTED VITROS VALP 82 UG/ML. PATIENT SAMPLE 15 VITROS VALP = 37.3 UG/ML VERSUS EXPECTED VITROS VALP 51 UG/ML. PATIENT SAMPLE 19 VITROS VALP = 46.5 UG/ML VERSUS EXPECTED VITROS VALP 61 UG/ML. PATIENT SAMPLE 20 VITROS VALP = 74.9 UG/ML VERSUS EXPECTED VITROS VALP 95 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VALP RESULTS WERE OBTAINED DURING A PATIENT CORRELATION AND THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS NOT PERFORMING ROUTINE VALP PATIENT TESTING AT THE TIME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 2012054 (B)(4).

    Description of Event or Problem · 0

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 2012054/ IVD 432003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426798 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-6393

    Patients

    Seq Age Sex Outcome Treatment
    1