BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 5785222 · Received July 12, 2016

    Report

    Report Number
    1628664-2016-00190
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 10, 2016
    Report Date
    April 13, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    THE INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A REVIEW OF INSTRUMENT SERVICE HISTORY, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER'S INSTRUMENT PRINTOUTS CONFIRMED THE TOTAL BILIRUBIN RESULTS PROVIDED. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS INVESTIGATION. A REVIEW OF THE ARCHITECT C401282 INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE OCCURRENCE AND NO SUBSEQUENT COMPLAINTS OF DISCREPANT RESULTS. A REVIEW OF ARCHITECT C4000 INSTRUMENT AND TOTAL BILIRUBIN REAGENT COMPLAINTS DID NOT IDENTIFY ANY TRENDS RELATED TO THE CUSTOMER'S ISSUE. A REVIEW OF THE ARCHITECT OPERATIONS MANUAL SHOWS ADEQUATE ASSISTANCE WITH RESPECT TO THE CUSTOMER'S OBSERVED ISSUE. BASED ON THE AVAILABLE INFORMATION THIS APPEARS TO HAVE BEEN AN ISOLATED EVENT. AN ISSUE WITH SAMPLE INTEGRITY/HANDLING COULD NOT BE RULED OUT SINCE THE ISSUE WAS ISOLATED TO A SINGLE SAMPLE PER THE COMPLAINT TEXT. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR A MALFUNCTION OF THE ARCHITECT C4000.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON A (B)(6) PATIENT. THE RESULTS PROVIDED WERE: SID (B)(4) ON (B)(6) 2016, 18:00 DRAW =21.2MG/DL (5 DAYS TO ONE MONTH CRITICAL VALUE >/=18.0MG/DL) / NEW SAMPLE AT 24:00 = 12.1 / REPEAT OF 18:00 SAMPLE ON (B)(6) 2016 = 11.9 ON C4000 / 12.1MG/DL ON C8000. THE CHILD WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION BUT NO ADDITIONAL TREATMENT OR MEDICATION WAS ADMINISTERED. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442157 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA LIST # 06L45-21