BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2161758 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01681
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR SEVERE DIABETIC KETOACIDOSIS. THE CUSTOMER DID NOT WANT TO PROVIDE FURTHER INFO. THE CUSTOMER STATED THAT SHE WAS NOT HAVING PROBLEMS WITH THE INSULIN PUMP. THE CUSTOMER FELT THAT SHE WAS HAVING PROBLEMS WITH THE GLUCOSE METER COMMUNICATING WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT GLUCOSE METER. PROVIDED THE CUSTOMER WITH THE PHONE NUMBER FOR THE GLUCOSE METER MFR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization