BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3260456 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-96378
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND CALLED TO REPORT A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CALLER STATED THAT HIS WIFE WAS IN A COMA, THE BLOOD GLUCOSE READING WAS 18 MG/DL. THE INSULIN PUMP MALFUNCTIONED AND DELIVERED THE ENTIRE AMOUNT OF INSULIN INTO HER BODY. U500 INSULIN WAS USED. ADVISED CUSTOMER THAT U100 INSULIN IS APPROVED FOR THE INSULIN PUMP. CUSTOMER NO LONGER USES THE INSULIN PUMP. THE CURRENT BLOOD GLUCOSE READING IS 129 MG/DL. CUSTOMER WAS HOSPITALIZED FOR THREE WEEKS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359354 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization