BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 2132133 · Received June 17, 2011

    Report

    Report Number
    1319809-2011-00039
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPEATABLE LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 5600 SYSTEM. PRECISION TESTING USING A DESIGNATED SYSTEM MARKER ASSAY AT THE TIME OF THE EVENT DEMONSTRATED ACCEPTABLE PERFORMANCE OF THE VITROS 5600 SYSTEM. HOWEVER, PRECISION TESTING USING THE AFFECTED VITROS PHYT SLIDE LOT (4786) WAS UNACCEPTABLE. ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBSERVED USING AN ALTERNATE LOT (1423) OF PHYT SLIDE CARTRIDGES. IMPROPER HANDLING OF OPENED PHYT SLIDE CARTRIDGES (OF THE IN-USE LOT 4786) WAS SUSPECTED AS THE CUSTOMER REMOVES PHYT CARTRIDGES FROM THE 5600 SYSTEM FOR CONTINUED LONG TERM STORAGE WHICH IS NOT IN ACCORDANCE WITH THE VITROS PHYT SLIDE INSTRUCTIONS FOR USE. FURTHER TESTING TO CONFIRM THIS AS A CONTRIBUTING FACTOR WAS NOT POSSIBLE AS THE CUSTOMER HAD DEPLETED THEIR INVENTORY OF THE AFFECTED PHYT SLIDE LOT (4786) AND NO OTHER SIMILAR COMPLAINTS WERE NOTED IN A COMPLAINT REVIEW. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE, HOWEVER, USER ERROR DUE TO IMPROPER HANDLING OF VITROS PHYT SLIDE CARTRIDGES CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPEATABLE LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULT WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. A VITROS PHYT RESULT OF 18.6 UG/ML VS AN EXPECTED RESULT OF 21.3 UG/ML WAS OBTAINED. A BIASED RESULT OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER HAD NO EVIDENCE THAT PATIENT 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2649-0120-4786

    Patients

    Seq Age Sex Outcome Treatment
    1