BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2851021 · Received November 29, 2012

    Report

    Report Number
    1628664-2012-00488
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 8, 2012
    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). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. THE SAFETY MEMO AND PRODUCTION EVALUATION INDICATED THAT THE ARCHITECT I2000SR IS CERTIFIED TO THE APPROPRIATE US, (B)(4), AND INTERNATIONAL SAFETY STANDARDS THAT APPLY TO ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE. A PART LIST NUMBER AND INSTRUMENT SERIAL NUMBER SEARCH WERE PERFORMED. THE LIST NUMBER SEARCH IDENTIFIED THREE SIMILAR COMPLAINTS FOR THE CUSTOMER DESCRIBED ISSUE IN WHICH THE SCC POWER SUPPLIES WERE REPLACED TO RESOLVED THE ISSUE TICKET TRENDING DATA IDENTIFIED NO ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH THE ISSUE OF SMOKE CAUSED BY THE POWER SUPPLY SCC-E PLATFORM. REVIEW OF THE PRODUCT LABELING REVEALED THAT THE ISSUE IN QUESTION IS ADEQUATELY ADDRESSED IN THE LABELING CLAIMS. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THE MALFUNCTION REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SMOKE COMING OUT OF THE ARCHITECT POWER SUPPLY. THE CUSTOMER SHUT DOWN THE ANALYZER AND NOTICED A BURNING MARK INSIDE THE SCC (SYSTEM CONTROL CENTER) POWER SUPPLY. NO INJURIES WERE REPORTED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE SCC WAS REPLACED IN ORDER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER SUPPLY SCC-E PLATFORM| POWER SUPPLY SCC-E PLATFORM