BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2133700 · Received June 9, 2011

    Report

    Report Number
    3004209178-2011-81707
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED WITH BLOOD GLUCOSE OVER 600 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER'S WIFE STATED THAT THE CUSTOMER HAD BEEN HAVING UNEXPLAINED HIGH BLOOD SUGARS, WHICH WAS ATTRIBUTED TO THE CUSTOMER BEING A BRITTLE DIABETIC. THE CUSTOMER'S WIFE STATED THAT SHE CHANGED THE CUSTOMER'S SET THE MORNING OF THE EVENT AND THAT THE CUSTOMER USES A QUICK-SET INFUSION SET. 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 PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET,| MODEL MMT-397, LOT 9201830