BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5171695 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-52326
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED THE DISPLACEMENT TEST. A33 ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE OR PROTRUDED DRIVE SUPPORT DISK. PUMP RECEIVED WITH LOOSE DRIVE SUPPORT DISK, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SYSTEM SENSOR AND THE RESERVOIR COMPARTMENT IS WET. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 98 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS DONE FOR ALARM AND WAS FOUND THAT THE DRIVE SUPPORT CAP WAS FLUSH AND NOT RECESSED INTO THE UNIT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701236 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR