BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7269438 · Received February 14, 2018

    Report

    Report Number
    1319808-2018-00010
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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 (B)(6) 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 AND HIGHER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED FROM NON-VITROS QC FLUIDS RUN ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED RESULTS WAS NOT DETERMINED. HOWEVER THE HIGHER THAN EXPECTED RESULT WAS MOST LIKELY DUE TO A SUBOPTIMAL CALIBRATION. HISTORICAL QUALITY CONTROL RESULTS INDICATE THE VALP REAGENT IS NOT A LIKELY CONTRIBUTING FACTOR TO THE EVENT, AS THE QC WAS ACCEPTABLE UP TO THE DAY OF THE EVENT. HOWEVER, A TRANSIENT ISSUE WITH THE INSTRUMENT OR THE REAGENT PACK IN USE AT THE TIME OF EACH EVENT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTORS TO THE EVENTS. THERE IS NO INDICATION OF AN INSTRUMENT ISSUE AS ACCEPTABLE WITHIN-RUN PRECISION RESULTS WERE OBTAINED INDICATING THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER AND LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS FROM NON-VITROS BIORAD CONTROL FLUIDS PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 LOT 31820 VITROS RESULTS 20.53 AND 21.77 UG/ML VERSUS EXPECTED 34 UG/ML. BIORAD L2 LOT 31820 VITROS RESULT OF 189.96 UG/ML VERSUS EXPECTED 140 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER CONFIRMED THAT NO ERRONEOUS PATIENT SAMPLE RESULTS WERE OBTAINED OR REPORTED. HOWEVER, THE INVESTIGATION CANNOT DEFINITIVELY 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. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114684 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-5974

    Patients

    Seq Age Sex Outcome Treatment
    1