BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 428822 · Received November 15, 2002

    Report

    Report Number
    2122870-2002-00032
    Event Type
    Other
    Date Received
    November 15, 2002
    Date of Event
    October 12, 2002
    Report Date
    November 15, 2002
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    10/2002: A SERVICE ENGINEER VISITED CUSTOMER TO ADDRESS SOME QUESTIONS REGARDING IMPRECISION. THE NEXT DAY: ANOTHER ENGINEER WAS DISPATCHED TO REPLACE THE SUBSTRATE LINES AND WAS TOLD BY THE CUSTOMER THAT AN ERRONEOUS LOWER HCG HAD BEEN REPORTED OUT OF THE LABORATORY IN 2002 AND THAT THE PATIENT'S TREATMENT HAD BEEN AFFECTED DUE TO THIS RESULT. ACCORDING TO THE CUSTOMER FEEDBACK, THE PHYSICIAN INFORMED THE PATIENT THAT THEIR PREGNANCY HAD BEEN TERMINATED BASED ON THE LOWER THAN EXPECTED HCG RESULT. PATIENT WAS RECEIVING PROGESTERONE THERAPY FOR VAGINAL BLEEDING, BUT WAS STOPPED AFTER RECEIPT OF ERRONEOUS LOWER BHCG RESULT. THE ERRONEOUS LOWER BHCG RESULT HAS AFFECTED PATIENT'S TREATMENT. BECKMAN COULTER FEELS THIS EVENT REQUIRES REPORTING UNDER 212 CFR 803. BHCG RANGES DURING NORMAL PREGNANCY ARE SUMMARIZED IN THE TABLE BELOW. APPROXIMATE GESTATIONAL AGE (WEEKS) 0.2-1, 1-2, 2-3, 3-4, APPROXIMATE HCG RANGE (MIU/ML, IU/L) 5-50, 50-500, 100-5,000, 500-10,000 APPROXIMATE GESTATIONAL AGE (WEEKS) 45, 56, 68, 812, APPROXIMATE HCG RANGE (MIU/ML, IU/L) 1,000-50,000, 10,000-100,000, 15,000-200,000, 10,000-100,000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS IMMUNOASSAY SYSTEM IN VITRO DIAGNOSTIC SYSTEM JJE BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other