BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 18691107 · Received February 12, 2024

    Report

    Report Number
    3016438761-2024-00084
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    January 23, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED TROUBLESHOOTING BY REANALYZING THE SAMPLES TO OBTAIN HIGHER RESULTS. THE CUSTOMER CONFIRMED THAT THE ISSUE WAS RESOLVED WITH THE REPLACEMENT OF ICT REFERENCE SOLUTION. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. THERE WAS NO ISSUE FOUND RELATED TO THE CURRENT COMPLAINT. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR 13 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 136-145 MMOL/L): INITIAL RESULT: REPEAT RESULT ON ALTERNATE ARCHITECT (MMOL/L): 1. 116 / 144, 2. 119 / 145, 3. 114 / 141, 4. 116 / 142, 5. 117 / 144, 6. 118 / 145, 7. 115 / 141, 8. 118 / 144, 9. 117 / 141, 10. 112 / 139, 11. 115 / 141, 12. 115 / 139, 13. 120 / 147, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159427 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown