BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 2981249 · Received February 27, 2013

    Report

    Report Number
    3005094123-2013-00018
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 19, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND RELATED TO THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSE POSITIVE BHCG RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED A BHCG RESULT OF 384.44 ON 02/14/2013. ON (B)(6) 2013 THE PATIENT WAS REDRAWN AND BHCG RESULTS OF <1.2 AND <1.2 WERE GENERATED. THE ORIGINAL SAMPLE WAS THEN REPEATED AND A BHCG RESULT OF <1.2 WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83352 ARCHITECT TOTAL B-HCG DHA A.I.D.D LONGFORD 21912JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03M74-01 SN (B)(4)| LN 03M74-01 SN (B)(4)| ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER