BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 479033 · Received August 12, 2003

    Report

    Report Number
    1628664-2003-00015
    Event Type
    Other
    Date Received
    August 12, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 11, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ISSUE REPORTED BY ON SITE ABBOTT FIELD SERVICE REP (FRS) IN 2003. CUSTOMER RUNS ALL B-HCG SAMPLES IN DUPLICATE AS PART OF LAB PROTOCOL. RESULTS OF <1.2 AND 825.56 WERE OBTAINED ON A SAMPLE. THE SAMPLE WAS BEING REPEATED AT THE TIME OF THE REPORT. REAGENT LOT IN USE WAS 89189M200. SAMPLE APPEARED NORMAL WITH NO FIBRIN, PARTICULATE MATTER, OR RBC'S. FSR REQUESTED TICKET OPENED TO PERFORM SERVICE ON THE INSTRUMENT. THE FSR FLUSHED THE SYSTEM AND INSPECTED THE PROBES BUT FOUND NO ISSUES FROM CUSTOMER IN 07/2003. A RESULT OF <10 HAD BEEN INADVERTENTLY REPORTED AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING GAVE RESULTS OF 796 AND 810. THE SAMPLE HAD BEEN STORED AT ROOM TEMPERATURE IN LAB RECEIVING PRIOR TO PROCESSING AND WAS THEN REFRIGERATED AFTER PROCESSING. AGE OF SAMPLE FROM DRAW TIME UNTIL RUN TIME WAS 3 HOURS. THE SAMPLE WAS ALSO RUN 10 TIMES ON ANOTHER ARCHITECT IN THE LAB, RESULTS WERE 816, 806, 811, 837, 824, 805, 822, 819, 862. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE INITIAL REPORTED RESULT, TREATMENT BASED ON REPEAT RESULT IS UNKNOWN. NO OTHER PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR LOT# 89189M200| ARCHITECT TOATL BHCG REAGENT LIST# 6C21-32,