BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LAC SLIDES

    MDR report key: 6111006 · Received November 17, 2016

    Report

    Report Number
    1319809-2016-00102
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED VITROS LAC QUALITY CONTROL RESULTS WERE OBTAINED FROM VITROS CONTROL FLUIDS USING TWO DIFFERENT LOTS OF VITROS LAC SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THERE IS NO EVIDENCE THAT A VITROS 350 SYSTEM OCCURRED. THE UNACCEPTABLE HISTORICAL VITROS LAC QUALITY CONTROL RESULTS OBTAINED FROM THE CUSTOMER INDICATE THAT THE VITROS LAC LOT 3530-0092-3271 WAS NOT PERFORMING AS INTENDED. HOWEVER, IT IS SUSPECTED THAT THE CUSTOMER IS NOT FOLLOWING CORRECT PROTOCOL WHEN RECONSTITUTING THE CALIBRATOR AND CONTROL FLUIDS BUT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED HIGHER AND LOWER THAN EXPECTED VITROS LAC QUALITY CONTROL RESULTS FROM VITROS CONTROL FLUIDS USING TWO DIFFERENT LOTS OF VITROS LAC SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LAC LOT 3530-0092-3271: PV2 LOT K4852 VITROS LAC RESULT 2.58*, 2.64*, 2.61*, 2.62*, 2.37*, 2.58*, 2.60*, 2.59*, 2.60*, 2.56*, 2.64*, 2.62*, 2.58*, 2.60*, AND 2.61* MMOL/L ,VERSUS THE EXPECTED VITROS LAC RESULT 3.96 MMOL/L; PV2 LOT M5007 VITROS LAC RESULTS 5.09*, 2.54* AND 5.19* MMOL/L VERSUS THE EXPECTED VITROS LAC RESULT 3.76 MMOL/L. VITROS LAC LOT 3531-0093-5063: PV1 LOT L5005 VITROS LAC RESULT 2.13* MMOL/L VERSUS THE EXPECTED VITROS LAC RESULT 1.39 MMOL/L; PV2 LOT M5007 VITROS LAC RESULT 5.67* MMOL/L VERSUS THE EXPECTED VITROS LAC RESULT 3.33 MMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ALTHOUGH THERE WERE NO REPORTS OF AFFECTED PATIENT SAMPLE RESULTS, IT CANNOT BE CONFIRMED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER NINE OF TWENTY MDR'S FOR THIS EVENT. TWENTY 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760612 VITROS CHEMISTRY PRODUCTS LAC SLIDES IN VITRO DIAGNOSTIC KHP ORTHO-CLINICAL DIAGNOSTICS 3530-0092-3271

    Patients

    Seq Age Sex Outcome Treatment
    1