BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 16631194 · Received March 28, 2023

    Report

    Report Number
    3016438761-2023-00163
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 13, 2023
    Report Date
    May 4, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT C16000 SERIAL NUMBER (B)(6) DUE TO A FALSE ELEVATED MAGNESIUM RESULT OBSERVED BY THE CUSTOMER. THE FSR PERFORMED ANALYZER MAINTENANCE AND REPLACED MULTIPLE PARTS INCLUDING THE C16 RGT PR(R)ROHS, WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO FALSE ELEVATED MAGNESIUM PATIENT RESULTS SINCE THE ANALYZER HAS BEEN SERVICED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE C16 RGT PR(R)ROHS. THE PRODUCT MONITORING REVIEW SCORECARD WAS REVIEWED AND FOUND NO TRENDS OF THE ARCHITECT C16000 WITH REGARDS TO THE CUSTOMER ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NONCONFORMANCES RELATED TO THE C16 RGT PR(R)ROHS. A LABELING REVIEW DETERMINED PRODUCT LABELING ADDRESSES TROUBLESHOOTING AND RESOLUTION OF THE CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 SERIAL NUMBER (B)(6) OR C16 RGT PR(R)ROHS WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED FROM AN ARCHITECT C16000 ANALYZER AND PROVIDED THE FOLLOWING SAMPLE DATA FOR 5 PATIENTS (CUSTOMER REFERENCE RANGE IS 1.70- 2.50 MG/DL). ON (B)(6) 2023 INITIAL RESULT WAS 6.92, REPEAT RESULT WAS 1.6. ON (B)(6) 2023 INITIAL RESULT WAS 8.80, REPEAT RESULT WAS 2.0. ON (B)(6) 2023 INITIAL RESULT WAS 7.78, REPEAT RESULTS WERE 1.9, 1.9, & 1.9. ON (B)(6) 2023 INITIAL RESULT WAS 8.07, REPEAT RESULT WAS 2.0. ADDITIONAL PATIENT RESULTS PROVIDED: INITIAL RESULT WAS 8.19, REPEAT RESULT WAS 2.0. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED FROM AN ARCHITECT (B)(4) ANALYZER AND PROVIDED THE FOLLOWING SAMPLE DATA FOR 5 PATIENTS (CUSTOMER REFERENCE RANGE IS 1.70- 2.50 MG/DL) ON (B)(6)2023 INITIAL RESULT WAS 6.92, REPEAT RESULT WAS 1.6. ON (B)(6) 2023 INITIAL RESULT WAS 8.80, REPEAT RESULT WAS 2.0. ON (B)(6) 2023 INITIAL RESULT WAS 7.78, REPEAT RESULTS WERE 1.9, 1.9, & 1.9. ON (B)(6) 2023 INITIAL RESULT WAS 8.07, REPEAT RESULT WAS 2.0. ADDITIONAL PATIENT RESULTS PROVIDED: INITIAL RESULT WAS 8.19, REPEAT RESULT WAS 2.0. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480102 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC MAGNESIUM(3750T), 03P68-32, 41375UN22.| CC MAGNESIUM(3750T), 03P68-32, 41375UN22.