BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2082203 · Received May 9, 2011

    Report

    Report Number
    1319809-2011-00010
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 10, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED. PERFORMANCE TESTING DETERMINED THAT THE VITROS 5600 SYSTEM WAS MOST LIKELY OPERATING AS EXPECTED AT THE TIME OF THE EVENT. CALIBRATION OF AN ALTERNATE LOT OF PHBR REAGENT SLIDES RESOLVED THE CUSTOMER ISSUE. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WHILE USING A VITROS 5600 INTEGRATED SYSTEM (MAS QC LEVEL 2 = 37.42 G/ML VS. EXPECTED RESULT 47.66 G/ML; TDM PV II = 21.51 G/ML VS. EXPECTED RESULT 27.43 G/ML). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO RECUR UNDETECTED WITH PATIENT SAMPLES. NO DISCREPANT PHBR PATIENT RESULTS WERE REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2532-0052-4961

    Patients

    Seq Age Sex Outcome Treatment
    1