BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3397220 · Received October 9, 2013

    Report

    Report Number
    1628664-2013-00278
    Event Type
    Malfunction
    Date Received
    October 9, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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

    SUSPECT MEDICAL DEVICE 1.; 2.; 4. CATALOG; SERIAL #; LOT # AND 11.HAVE BEEN CORRECTED FROM: 1. CLIN CHEM MAGNESIUM TO ARCHITECT C4000 2. MAGNESIUM, PRODUCT CODE: JGJ TO ANALYSER, CLINICAL CHEMISTRY, PRODUCT CODE JJE 4. CATALOG # 07D70-21 TO 02P24-40 LOT # REMOVED SERIAL # ADDED (B)(4). FROM ARCHITECT C4000 ANALYZER; LIST # 02P24-40; SERIAL # (B)(4) TO CLINICAL CHEMISTRY MAGNESIUM; LIST 07D70-21: LOT # 51459UN13 THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM AND DISCREPANT TRIGLYCERIDE RESULTS ON THE ARCHITECT C4000 INSTRUMENT, SERIAL NUMBER (B)(4). REVIEW OF COMPLAINT TEXT HAS ERROR CODE 1052 (UNABLE TO CALCULATE RESULT, ENDPOINT ABSORBANCE READS ARE UNSTABLE) GENERATED WHILE TESTING A PATIENT SAMPLE FOR TRIGLYCERIDE. ABBOTT FIELD SERVICE PERFORMED INSTRUMENT TROUBLESHOOTING AND REPLACED SEVERAL PARTS. REPLACEMENT OF THESE PARTS RESOLVED THE MAGNESIUM AND TRIGLYCERIDE ISSUES. PRODUCT LABELING WAS REVIEWED AND FOUND THAT THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE MAGNESIUM AND TRIGLYCERIDE REAGENT PACKAGE INSERTS CONTAIN ADEQUATE INFORMATION TO ADDRESS THE DESCRIBED ISSUE. REVIEW OF THE INSTRUMENT SERVICE TICKET HISTORY FOR SERIAL NUMBER (B)(4), DID NOT IDENTIFY ANY OTHER ISSUES THAT WERE A CONTRIBUTING FACTOR IN THE CURRENT COMPLAINT. A SINGLE DEFINITIVE CAUSE FOR THE FALSELY ELEVATED MAGNESIUM RESULTS AND TRIGLYCERIDE ISSUE WAS NOT ESTABLISHED. THERE WAS INSUFFICIENT INFORMATION AVAILABLE TO REASONABLY SUGGEST A MALFUNCTION OCCURRED, AND NO SYSTEMIC DEFICIENCY OF THE PARTS WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED MAGNESIUM RESULTS ON ONE PATIENT. THE PATIENT ((B)(6)) SAMPLE WAS RUN ON (B)(6) 2013 AND THE RESULTS PROVIDED WERE: INITIAL = 6.180 / REPEAT = 1.692MG/DL (NORMAL RANGE IS 1.6 - 2.6MG/DL). THE QC RESULTS FOR MAGNESIUM FROM (B)(6) 2013 WERE: LEVEL 1 = 1.052 (RANGE 0.92-1.32) AND LEVEL 3 = 4.078 (RANGE 3.85-4.45). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511158 ARCHITECT C4000 ANALYZER JJE ABBOTT MANUFACTURING INC 51459UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 ANALYZER, LIST # 02P24-40,| SERIAL # (B)(4)| CLINICAL CHEMISTRY MAGNESIUM, LIST 07D70-21:| LOT # 51459UN13