BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110092 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01908
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE OF 300 MG/DL, AND WAS ON LIFE SUPPORT. THE MOTHER JUST STATED THAT THE CUSTOMER WAS NOT FEELING WELL. THE MOTHER DID NOT HAVE THE INSULIN PUMP WITH HER AT THE TIME OF THE CALL. THEREFORE TROUBLESHOOTING COULD NOT BE CONDUCTED. THE MOTHER STATED THAT THEY JUST WANTED THE INSULIN PUMP REPLACED. ADVISED THAT WE CANNOT REPLACE THE INSULIN PUMP UNTIL WE CAN VERIFY THE SERIAL NUMBER. THE CUSTOMER OR MOTHER WAS TO CALL BACK WITH THAT INFORMATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210700 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization