BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2412179 · Received January 7, 2012

    Report

    Report Number
    MW5023770
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 7, 2012
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED PARADIGM INSULIN PUMP (B)(4). UNSOLICITED BOLUS GIVEN WITHOUT PT INVOLVEMENT. ON MONDAY (B)(6) 2011 AT 20:55 I TESTED MY BLOOD SUGAR WITH A RESULT OF 459. I ENTERED THAT NUMBER INTO THE PUMP BOLUS WIZARD. WITH THE CALCULATION FROM THE PUMP PROGRAM THE RECOMMENDED BOLUS WAS 7.8 UNITS OF INSULIN WHICH I DELIVERED AND I WENT TO BED. AT 23:04 THE PUMP GAVE AN UNSOLICITED MAX BOLUS OF 20 UNITS WHILE I WAS ASLEEP AND WITHOUT ANY INTERACTION FROM ME. I AWOKE AT 00:56 TO THE LOW BLOOD SENSOR ALARM; I TESTED WITH A METER RESULT OF 25. THE INSULIN REACTION I EXPERIENCED WAS MY WORST EVER AND I RECOVERED ONLY BECAUSE OF THE INTERVENTION FROM MY WIFE FORCING TWO TUBES OF INSTA GLUCOSE INTO MY MOUTH, A CAN OF PINEAPPLE JUICE, AND A HALF A BOTTLE OF (B)(4) CORN SYRUP. I COLLAPSED ONTO THE FLOOR WHICH RESULTED IN A SPRAINED LEFT ANKLE, RIGHT KNEE, AND I DISLOCATED, BROKE AND CHIPPED THE NUMBER TWO TOE ON MY RIGHT FOOT. THESE INJURIES RESULTED IN MISSING TWO WEEKS OF WORK AND REQUIRE THE WEARING OF A WALKING CAST. I RETURNED THE PUMP TO MINIMED ON (B)(6) 2011. I KEPT A PICTURE OF THE PUMP AND A REPORT OF THE BLOOD SUGARS AND BOLUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PARADIGM INSULIN PUMP 522 6025130-OU1 052505 LZG MMT-522LNAL IC: 3408B-512

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other ENALAPRIL 5 MG 1 X DAY MORNING| METHIMAZOLE 10 MG X DAY MORNING| PRAVASTATIN 20MG 1 X DAY MORNING| PRAMIPEXOLE .25MG 4 X DAY EVENING| HUMALOG REG INSULIN DELIVERED BY THE INSULIN PUMP