BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4923222 · Received July 17, 2015

    Report

    Report Number
    2032227-2015-22511
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL OF THE BUTTONS FUNCTIONED PROPERLY, HOWEVER MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING OUR TESTING. NO MOISTURE DAMAGE WAS FOUND INSIDE THE INSULIN PUMP NOTED. THE INSULIN PUMP FUNCTIONED PROPERLY DURING FUNCTIONAL CHECK INCLUDING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF TEST, A21 TEST AND ALL OPERATING CURRENT TEST WERE NORMAL. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE WINDOW CORNERS AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 5.6 MMOL/L. THE CUSTOMER REPORTED CAMPING IN THE RAIN PRIOR TO THE ALARM OCCURRING. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464801 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1