BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT

    MDR report key: 2102810 · Received May 25, 2011

    Report

    Report Number
    3007111389-2011-00062
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE, HIGHER THAN EXPECTED VITROS ANTI-HAV IGM RESULTS WERE OBTAINED FOR A SINGLE PATIENT SAMPLE. THE INVESTIGATION DETERMINED THAT THE SAMPLE INVOLVED MAY NOT HAVE BEEN PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, MAY HAVE BEEN PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE THAT THE VITROS ANTI-HAV IGM REAGENT OR VITROS ECIQ SYSTEM MALFUNCTIONED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AN UNKNOWN SAMPLE INTERFERENT OR PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED REPRODUCIBLE, HIGHER THAN EXPECTED VITROS ANTI-HAV IGM PATIENT RESULTS (VITROS ECIQ ANTI-HAV IGM RESULTS = (B)(6)) (VITROS 3600 ANTI-HAV IGM RESULT = (B)(6)) FOR A SINGLE PATIENT SAMPLE WHEN COMPARED TO AN ALTERNATE OEM ANALYZER ((B)(6)) WHILE USING THE VITROS ECIQ AND 3600 ANALYZERS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT IN-VITRO DIAGNOSTIC LOL ORTHO-CLINICAL DIAGNOSTICS 2550

    Patients

    Seq Age Sex Outcome Treatment
    1