BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2760960 · Received September 26, 2012

    Report

    Report Number
    1319809-2012-00244
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 26, 2012
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. RESULTS OF PRECISION TESTING INDICATED THAT THE VITROS 5,1 FS CHEMISTRY SYSTEMS WERE OPERATING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION TO DATE HAS NOT IDENTIFIED A DEFINITIVE ROOT CAUSE, AND THE INVESTIGATION IS ONGOING. A REAGENT RELATED ISSUE OR AN INTERACTION BETWEEN THE VITROS PHBR SLIDES AND THE VITROS 5,1 FS CHEMISTRY SYSTEM HAVE NOT BEEN RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED AFTER USING AN ALTERNATE VITROS PHBR REAGENT LOT. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM AS FOLLOWS: QC LOT K1912 (EXPECTED VALUE = 10.36 G/ML): 6.46 G/ML; QC LOT L1913 (EXPECTED VALUE = 27.40 G/ML): 17.54, 36.60 G/ML; QC LOT M1914 (EXPECTED VALUE = 57.89 G/ML): 43.77, 41.86, AND 42.13 G/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PREVIOUSLY REPORTED VITROS PHBR PATIENT RESULTS WERE QUESTIONED WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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 2538-0060-8971

    Patients

    Seq Age Sex Outcome Treatment
    1