BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 6298660 · Received February 2, 2017

    Report

    Report Number
    1319808-2017-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    December 30, 2016
    Report Date
    February 2, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER ORTHO FIELD SERVICE PERFORMED ACTIONS TO OPTIMIZE THE VITROS 5,1 FS SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT WAS NOT IDENTIFIED. A WITHIN-RUN VALP PRECISION TEST WAS AS EXPECTED, INDICATING THE VIROS VALP REAGENT LOT 2511-25-5263 WAS NOT A LIKELY CONTRIBUTING FACTOR TO THE EVENT. THERE WAS NO EVIDENCE TO SUGGEST A VITROS 5,1FS CHEMISTRY SYSTEM MALFUNCTION; HOWEVER, AN UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR AS PRE-SERVICE PRECISION TESTING TO ASSESS INSTRUMENT PERFORMANCE BEFORE SERVICE WAS NOT UNDERTAKEN. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS USING MULTIPLE LEVELS OF NON-VITROS BIORAD CONTROL FLUIDS ON A VITROS 5,1 FS CHEMISTRY SYSTEM: BIORAD-1= 22.17 UG/ML VERSUS EXPECTED 35.4 UG/ML; BIORAD-2= 58.10 UG/ML VERSUS EXPECTED 78.2 UG/ML; BIORAD-3= 81.24 UG/ML VERSUS THE EXPECTED 108.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED OR REPORTED FROM THE LABORATORY, 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 PATIENT HARM AS A RESULT OF THIS EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78330 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-5263

    Patients

    Seq Age Sex Outcome Treatment
    1