BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3120353 · Received May 20, 2013

    Report

    Report Number
    1628664-2013-00135
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGJ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ABBOTT FIELD SERVICE EVALUATION, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. AN ABBOTT FIELD SERVICE REPRESENTATIVE COMPLETED TROUBLESHOOTING OF THE INSTRUMENT WHICH INVOLVED PART REPLACEMENTS. THE OPTIC ERRORS WERE RESOLVED ONCE THE DAQ BOARD WAS REPLACED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. INFORMATION REGARDING PROPER CENTRIFUGATION WAS PROVIDED TO THE CUSTOMER, AS INDICATED IN THE OPERATIONS MANUAL. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT C8000 ANALYZER, LN 01G06 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT FOR 1 PATIENT WHILE USING THE ARCHITECT C8000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (MMOL/L): SID (B)(4): INITIAL 3.70, RETEST: 0.43, 0.42. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221785 ARCHITECT C8000 SYSTEM JGJ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CLINICAL CHEMISTRY MAGNESIUM| LN 03P68-21, LOT 15653UN12| LN 03P68-21, LOT 15653UN12| CLINICAL CHEMISTRY MAGNESIUM