BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3594408 · Received January 28, 2014

    Report

    Report Number
    1628664-2014-00010
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 5, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED RESULTS WERE ASSIGNED TO THE WRONG SID (BARCODE) ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (THE (B)(6) INITIAL RESULTS WERE MIXED UP. THE REPEAT RESULTS WERE RUN ON (B)(6).) SID (B)(6). CHOLESTEROL INITIAL 191, REPEAT 231, 235. DHDL INITIAL 93, REPEAT 72, 73. TRIGLYCERIDES INITIAL 40, REPEAT 84, 84. SID(B)(6). CHOLESTEROL INITIAL 233, REPEAT 199, 212. DHDL INITIAL 65, REPEAT 91, 89. TRIGLYCERIDES INITIAL 80, REPEAT 57, 57. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61017 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1