BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 2523438 · Received April 9, 2012

    Report

    Report Number
    1628664-2012-00222
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    PMA / PMN Number
    K981578
    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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT SERVICE HISTORY WAS REVIEWED AND BASED ON THE AVAILABLE INFORMATION, NO OTHER TICKETS WERE FOUND RELATED TO THIS COMPLAINT. A SEARCH FOR SIMILAR COMPLAINTS WAS PERFORMED; ONE OTHER COMPLAINT FOR ERRATIC CALCIUM RESULTS WAS CLOSED WITH NO DEFICIENCY, AND TWO OTHER TICKETS FOR ERRATIC CALCIUM RESULTS WERE CLOSED THROUGH NORMAL TROUBLESHOOTING OR ARE STILL IN-PROCESS. THE ARCHITECT CALCIUM REAGENT PACKAGE INSERT AND ARCHITECT SYSTEM OPERATIONS MANUAL CONTAIN ADEQUATE LABELING FOR SAMPLE PRECAUTIONS AND TROUBLESHOOTING OF ERRATIC RESULTS. BASED UPON THE AVAILABLE DATA AND THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSELY ELEVATED CLINICAL CHEMISTRY CALCIUM RESULT OF 3.15 MMOL/L (12.6 MG/DL) WAS GENERATED WHEN REAGENT LOT 06879UN11 WAS IN USE. REPEAT TESTING OF THE SAMPLE GENERATED A RESULT OF 2.36 MMOL/L (9.4 MG/DL), WITH RESULTS OF 2.34 MMOL/L (9.36 MG/DL) GENERATED ON A SECOND ARCHITECT IN THE LAB. THE CUSTOMER WAS ADVISED TO PERFORM A CONTAMINATION TEST WITH CREATININE AND CALCIUM TO DETERMINE IF THERE WAS A PROBLEM. THE CUSTOMER PERFORMED FIVE RUNS OF THE CONTAMINATION TEST AND NO ISSUES WERE IDENTIFIED. THE FALSELY ELEVATED CALCIUM RESULT WAS NOT REPORTED TO THE MEDICAL PROVIDER, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY CALCIUM CJY ABBOTT MANUFACTURING INC 06879UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000, LIST #1G06-01, SN (B)(4)| ARCHITECT C8000, LIST#1G06-01, SN (B)(4)