BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2896814 · Received January 4, 2013

    Report

    Report Number
    1628664-2013-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLE SHOOTING WAS PERFORMED, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. TROUBLESHOOTING WAS PERFORMED AND THE R2 REAGENT PROBE WAS REPLACED AND NO FURTHER ISSUES HAVE ACCRUED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF ARCHITECT C16000 PROCESS MODULE, LIST NUMBER 03L77 WAS IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER INDICATED THAT THEY OBSERVED A FALSELY ELEVATED CREATININE RESULT WHILE USING THE ARCHITECT C16000 PROCESS MODULE. THE CUSTOMER STATED THEY GENERATED AN INITIAL RESULT OF 7.41 MG/DL, WHICH WAS RETESTED ON ANOTHER ARCHITECT C16000 INSTRUMENT GENERATING A RESULT OF 1.15 MG/DL. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4404 ARCHITECT C16000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINCAL CHEMISTRY CREATININE| CLINICAL CHEMISTRY CREATININE| LN 03L81-32, LOT UNKNOWN| LN 03L81-32, LOT UNKNOWN