BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2041745 · Received March 29, 2011

    Report

    Report Number
    3004209178-2011-80857
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 TREATED TWICE BY PARAMEDICS FOR HYPOGLYCEMIA, WITH ONE BLOOD GLUCOSE READING AROUND 30 MG/DL. THE CUSTOMER'S DAUGHTER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD TWO STINTS PLACED AROUND HER HEART LAST SUMMER AND WAS CURRENTLY ON BLOOD THINNERS. THE CUSTOMER STATED THAT A WEEK PRIOR TO THE EVENT, SHE HAD TO VISIT A PSYCHIATRIST DUE TO DISTRESS OVER INABILITY TO CONTROL HER BLOOD GLUCOSE LEVELS. THE CUSTOMER HAS USED THE MODEL MMT-398 QUICK-SET INFUSION SET AND A SILHOUETTE INFUSION SET. PROGRAMMING WAS CORRECT. 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 PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention MODEL MMT-398| UNOMEDICAL QUICK-SET INSULIN INFUSION SET:| UNOMEDICAL SILHOUETTE INSULIN INFUSION SET