BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7036268 · Received November 16, 2017

    Report

    Report Number
    1319681-2017-00112
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 26, 2017
    Report Date
    November 16, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FOR NON-VITROS (BIORAD) QUALITY CONTROL FLUIDS USING VITROS DGXN SLIDE LOTS 1913-0246-2323 AND 1913-0246-3800, TESTED ON A VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULT IS AN INSTRUMENT PERFORMANCE ISSUE, AS A WITHIN-RUN VITROS DGXN PRECISION TEST WAS OUTSIDE PERFORMANCE GUIDELINES, INDICATING THAT THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED. IN ADDITION, HISTORICAL VITROS DGXN QUALITY CONTROL RESULTS INDICATED A WITHIN LABORATORY PRECISION ISSUE. FOLLOWING SERVICE ACTIONS WHICH INCLUDED REPLACEMENT OF THE IMMUNO WASH FLUID SHUTTLE REGISTRATION EXTENSION SPRING WHICH WAS MISSING, ACCEPTABLE VITROS DGXN WITHIN LAB QUALITY CONTROL RESULTS WERE OBTAINED, INDICATING SERVICE ACTIONS HAD RETURNED THE VITROS 5600 SYSTEM TO EXPECTED PERFORMANCE. THERE IS NO EVIDENCE THAT VITROS DGXN SLIDE LOTS 1913-0246-2323 AND 1913-0246-3800 WERE NOT PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) QUALITY CONTROL RESULTS FROM A NON-VITROS QUALITY CONTROL (QC) FLUID, WHEN COMPARED TO THE CUSTOMERS ESTABLISHED MEAN. THE RESULT WAS GENERATED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD QC LEVEL 3 LOT 40953 VITROS DGXN RESULTS 1.88 AND 1.92 NG/ML VERSUS EXPECTED MEAN 3.45 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1953824/QERTS RECORD ID 419219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815482 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1