BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4122998 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29538
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP GOT WET IN A RAIN STORM. HE STATED LIGHTNING HIT THE GROUND A FEW FEET FROM WHERE HE WAS. THERE WAS WATER IN THE INSULIN PUMP. CUSTOMER STATED THE DEVICE HAS NO ALARMS, BLANKS DISPLAY, OR ANY OTHER TYPE OF DAMAGE. THE DEVICE PASSED A SELF TEST. CUSTOMER STATED HIS SENSOR READINGS HAVE BEEN INACCURATE. CUSTOMER'S CALL WAS TRANSFERRED TO A SENSOR TECHNICAL SPECIALIST. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600362 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR