BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 2912106 · Received January 11, 2013

    Report

    Report Number
    1319808-2013-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT SUDDEN SHIFTS IN VITROS VANC QUALITY CONTROL RESULTS WERE OBSERVED ON A VITROS 5,1 FS CHEMISTRY SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A REAGENT ISSUE WITH VITROS VANC LOT 2514-24-2433 RELATED TO THE SPECIFIC REAGENT PACKS IN USE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. IN ADDITION, IMPROPER STORAGE HANDLING OF THE AFFECTED VITROS VANC REAGENT PACKS COULD NOT BE RULED OUT ENTIRELY. EXPECTED PERFORMANCE ON VITROS 5,1 FS CHEMISTRY SYSTEM WAS RETURNED FOLLOWING RECALIBRATION OF VITROS VANC REAGENT USING AN ALTERNATE REAGENT PACK. EXPECTED PERFORMANCE ON VITROS 4600 CHEMISTRY SYSTEM WAS RETURNED USING AN ALTERNATE REAGENT LOT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SUDDEN SHIFTS IN VITROS VANC QUALITY CONTROL RESULTS PROCESSED ON A VITROS 5, 1 FS CHEMISTRY SYSTEM AND A VITROS 4600 CHEMISTRY SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED USING VITROS TDM PV CONTROL FLUIDS: PROCESSED ON VITROS 5,1 FS ANALYZER (SHIFT LOW): QC FLUID LOT H1648: 9.09, 9.00, 9.36, 8.99, 10.13 VS. AN EXPECTED RESULT= 20.2 G/ML. QC FLUID LOT J1649: 17.06, 16.81, 17.70, 17.10, 18.81 VS. AN EXPECTED RESULT= 38.8 G/ML. PROCESSED ON VITROS 5,1 FS ANALYZER (SHIFT HIGH): QC FLUID LOT G1647: 30.72 VS. AN EXPECTED RESULT= 7.1 G/ML. QC FLUID LOT H1648: >50.0 VS. AN EXPECTED RESULT= 20.02 G/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS VANC WHILE THE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17066 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-24-2433

    Patients

    Seq Age Sex Outcome Treatment
    1