BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK

    MDR report key: 3612635 · Received February 7, 2014

    Report

    Report Number
    1319808-2014-00008
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 9, 2014
    Report Date
    February 6, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. QUALITY CONTROL RESULTS SHIFTED LOW SUDDENLY FOLLOWING THE INTRODUCTION OF SPECIFIC VALP REAGENT PACKS. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS 5600 INTEGRATED SYSTEM AND VITROS VALP REAGENT WERE OPERATING AS EXPECTED AT THE TIME OF THE EVENT, AND ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED USING THE SAME REAGENT ON AN ALTERNATE VITROS INSTRUMENT. FOLLOWING COMPLETION OF MAINTENANCE/DIAGNOSTIC ACTIONS AND RECALIBRATION OF THE SAME VITROS VALP REAGENT LOT, ACCEPTABLE PERFORMANCE WAS ACHIEVED AND HAS BEEN MAINTAINED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS EVENT. THERE WAS NO APPARENT CHANGE IN INSTRUMENT CONDITIONS (SUCH AS A SERVICE EVENT) THAT WOULD NECESSITATE RECALIBRATION, AND THE NEED FOR PERIODIC RECALIBRATION OF A GIVEN REAGENT LOT IS TYPICALLY ASSOCIATED WITH A MORE GRADUAL DRIFT IN RESULTS OVER TIME RATHER THAN A SUDDEN SHIFT AS WAS OBSERVED IN THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM USING 2 DIFFERENT VITROS VALP LOT 2511-21-2896 REAGENT PACKS (PACK 2197 AND 2216). (B)(4). BIORAD-1= 20.3 AND 20.2 UG/ML VERSUS EXPECTED 32.6 UG/ML. BIORAD-2= 100.9 UG/ML VERSUS EXPECTED 126.4 UG/ML. (B)(4). BIORAD-1= 20.7 UG/ML VERSUS EXPECTED 32.6 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. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80476 VITROS CHEMISTRY PRODUCTS VALP REAGENT PACK IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-21-2896

    Patients

    Seq Age Sex Outcome Treatment
    1