BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173606 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38606
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO UNLOCKED KEYPAD CONNECTOR. UNABLE TO VERIFY FAILED BATTERY TEST AND PERFORM THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST DUE TO NO BUTTON RESPONSE. ALSO RECEIVED WITH CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ACT BUTTON ON HIS INSULIN PUMP WAS NOT WORKING. HE ALSO STATED THE NUMBERS WERE NOT RAMPING UP ON THEIR OWN AND THAT THERE WAS SOME RESPONSE TO BUTTON PRESS. THE CUSTOMER ALSO STATED THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL. HE HAD TREATED HIS BLOOD GLUCOSE WITH FOOD. HE ALSO DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653012 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR