BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER #2

    MDR report key: 262251 · Received February 10, 2000

    Report

    Report Number
    MW1018124
    Event Type
    Malfunction
    Date Received
    February 10, 2000
    Date of Event
    October 1, 1998
    Report Date
    February 9, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    IQW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HEPATITIS B SURFACE ANTIGEN TESTING. INITIAL INSTALLATION OF SOFTWARE WAS SET UP WITH DIFFERENT PARAMETERS INTENDED TO BE THE SAME. DIFFERENT SOFTWARE PARAMETERS RESULTED IN DIFFERENT CUT OFF LIMITS. APPROX 97 PTS WERE REPORTED AS NEGATIVE BUT COULD HAVE FALLEN IN AN INDETERMINATE RANGE. INDETERMINATE FINDINGS ARE ROUTINELY REPEATED AND MOST OFTEN FOUND TO BE NEGATIVE. STAFF RESEARCHING HOW MANY WERE RE-TESTED BECAUSE OF CONTINUED SYMPTOMS. PHYSICIAN NOTIFICATION UNDERTAKEN AND REPEAT TESTING WILL BE OFFERED. DIFFERENT SOFTWARE PARAMETERS WERE PRESENT PREVIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER #2 SOFTWARE IQW ABBOTT LABORATORIES FLEXIBLE PIPETTING CENTER #2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other