BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 12463342 · Received September 13, 2021

    Report

    Report Number
    3016438761-2021-00325
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 1, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE WAS INADVERTENTLY OMITTED IN PREVIOUS REPORT.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND REPLACED THE PUMP, PROBE WASH, 16 (ROHS) (7-202557-02). PART REPLACEMENT RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT C16000 PROCESSING MODULE SERIAL NUMBER(B)(6) REVEALED NO ADDITIONAL ERRRATIC OR DISCREPANT PATIENT RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE PUMP, PROBE WASH, 16 (ROHS) (7-202557-02) DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE PUMP, PROBE WASH, 16 (ROHS) (7-202557-02) OR THE ARCHITECT C16000 PROCESSING MODULE SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER IDENTIFIED FALSELY ELEVATED MAGNESIUM RESULTS FOR 1 PATIENT. THE CUSTOMER USES THE REFERENCE RANGE IS 1.6 ¿ 2.6 MG/DL. THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL RESULT 4.4 MG/DL, REPEATED 1.1 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358317 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CC MAGNESIUM(3750T), 03P68-32, 09151UN21| CC MAGNESIUM(3750T), 03P68-32, 09151UN21| CC MAGNESIUM(3750T), 03P68-32, 09151UN21