BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3951361 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88075
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF OVER 1000 MG/DL. THE CUSTOMER WAS CALLING FROM THE HOSPITAL SINCE THEY ARE STILL HOSPITALIZED. THE DAY PRIOR TO THE HOSPITALIZATION THE INSULIN PUMP ALARMED NO DELIVERY, SO THE CUSTOMER CHANGED THE INFUSION SET AND WAS ABLE TO CLEAR THE ALARM. AT THE TIME OF THE EMERGENCY ROOM VISIT THE CUSTOMER WAS LIGHTHEADED, DEHYDRATED, HAD DRY MOUTH, HEAVY BREATHING, AND COULD NOT TALK. THE CUSTOMER WAS TREATED WITH INSULIN DRIP TO BRING THE BLOOD GLUCOSE DOWN, THEN TRIED TO PUT THE INSULIN PUMP BACK ON OVERNIGHT, BUT STARTED GETTING NO DELIVERY ALARM. THEY WERE PLACED BACK ON INSULIN DRIP AND CURRENTLY ARE ON MANUAL INJECTIONS OF LANTUS. THE BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 214 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE BATTERY OF THE DEVICE WAS DEAD. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428712 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization