BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232429 · Received August 26, 2011

    Report

    Report Number
    2032227-2011-02183
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT HE WAS HOSPITALIZED DUE DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS OVER 400 MG/DL. THE CUSTOMER DID NOT PROVIDE FURTHER INFO ABOUT THE EVENT. THE CUSTOMER REQUESTED ASSISTANCE WITH AN INFUSION SET CHANGE DUE TO NO DELIVERY ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization UNOMEDICAL QUICK-SET| MMT-397| PARADIGM INSULIN INFUSION SET