BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2033813 · Received March 17, 2011

    Report

    Report Number
    3004209178-2011-80695
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE LEVELS OF 60 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, SHE HAD SEEN THE DR FOR BACK AND STOMACH PAINS, WHICH THE DR. DISCOVERED WAS KIDNEY STONES. SUBSEQUENTLY, THE DR. SENT THE CUSTOMER TO THE HOSPITAL WHERE THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WORE HER INSULIN PUMP THROUGH THE CT SCAN. THE CUSTOMER ALSO STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS THE FOLLOWING DAY AND HAD TO BE TREATED BY HER SISTER. THE CUSTOMER FURTHER STATED SHE HAD BEEN STRUGGLING WITH A RESERVOIR PROBLEM AND HAD A SEVERELY BENT NEEDLE ON HER 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 39 YR Hospitalization 32", 9MM| UNOMEDICAL PARADIGM QUICK-SET INFUSION SET