BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 4243958 · Received November 11, 2014

    Report

    Report Number
    1319808-2014-00028
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC NON-VITROS BIORAD QUALITY CONTROL L3 RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE IS UNKNOWN, HOWEVER; A TRANSIENT ISSUE WITH THE VITROS VANC REAGENT PACK, AN UNKNOWN ISSUE WITH THE BIORAD CONTROL, OR A PRE-ANALYTICAL SAMPLE MIX UP CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS UNKNOWN IF AN INSTRUMENT ISSUE THAT WAS ADDRESSED BY SERVICE CONTRIBUTED TO THE LOWER THAN EXPECTED VANC RESULTS AS NO PRECISION PERFORMANCE TESTING WAS PROCESSED PRIOR TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VANC NON-VITROS BIORAD QUALITY CONTROL L3 RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIORAD L3 RESULTS OF <0.5UG/ML (X2) VS. THE EXPECTED RESULT OF 32.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED, HOWEVER, THE INVESTIGATION COULD NOT CONCLUDE THAT PATIENT RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S 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
    726126 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTIC LEH ORTHO-CLINICAL DIAGNOSTICS 2514-31-3700

    Patients

    Seq Age Sex Outcome Treatment
    1