BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3003973 · Received March 14, 2013

    Report

    Report Number
    1628664-2013-00057
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND A REVIEW OF THE INSTRUMENT SERVICE HISTORY. A REVIEW OF COMPLAINT DATA FOR THE INSTRUMENT DID NOT IDENTIFY ANY ADVERSE COMPLAINT TRENDS IDENTIFIED FOR A SIMILAR ISSUE. THERE WAS NO ERROR OR PROBLEM WITH ARCHITECT I2000SR, SERIAL NUMBER (B)(4). ARCHITECT ISYSTEM SERVICE AND SUPPORT MANUAL (96211-127) PROVIDES ADEQUATE SPECIFICATIONS AND CRITERIA FOR I2000SR LIQUID WASTE OPTIONS. ARCHITECT SYSTEM OPERATIONS MANUAL (REVISION NUMBER 201837-110) PROVIDES ADEQUATE INFORMATION REGARDING EXPOSURE AND HANDLING OF POTENTIALLY INFECTIOUS MATERIALS AND HANDLING AND DISPOSAL OF LIQUID WASTE. THE CUSTOMER WAS ASKED TO FOLLOW THEIR FACILITY'S MANAGEMENT STANDARD FOR AN ACCIDENTAL INJECTION. THE FACILITY STAFF MEMBER, WHO WAS EXPOSED, WAS MEASURED FOR THE FOLLOWING ARCHITECT INFECTIOUS DISEASE ASSAYS: (B)(6). AT THIS TIME, ALL THE RESULTS WERE (B)(6). THE STAFF MEMBER WILL BE RETESTED IN 3 MONTHS. BASED UPON THE DATA AVAILABLE, NO MALFUNCTION OR DEFICIENCY OF THE ARCHITECT I2000SR INSTRUMENTS WAS IDENTIFIED RELATIVE TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT WASTE FLUID DRAINED TO THE LOWER FLOOR DUE TO A CLOGGED DRAIN OUTLET. A STAFF MEMBER ON THE LOWER FLOOR SWALLOWED A DROP OF THE WASTE FLUID. THE STAFF MEMBER WAS THEN TESTED FOR THE FOLLOWING INFECTIOUS DISEASES THAT THE FACILITY RUNS: HBSAG, AUSAB, HBC II, HBEAG, HBEAB, HCV, HTLV, AND HIV AG/AB - ALL RESULTS WERE NONREACTIVE. THE STAFF MEMBER WILL BE RETESTED ON THESE SAME ASSAYS IN THREE MONTHS. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE IMPACT TO THE EMPLOYEE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ON THE EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107782 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1