BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2081255 · Received April 26, 2011

    Report

    Report Number
    2032227-2011-01028
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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 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 DUE TO HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 451 MG/DL AT THE TIME OF THE EVENT. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC SEIZURE, WITH A BLOOD GLUCOSE READING OF 21 MG/DL. THE CUSTOMER'S BOYFRIEND WAS ABLE TO ASSIST HER BY TREATING WITH FOOD, BUT LATER THAT AFTERNOON, THE CUSTOMER BEGAN TO VOMIT, WHICH RESULTED IN HER GOING TO THE HOSPITAL. IT WAS DETERMINED THAT THE CUSTOMER WAS INADVERTENTLY USING RECALLED QUICK-SET INFUSION SETS. THE CUSTOMER STATED THAT SHE IS NO LONGER IN POSSESSION OF ANY RECALLED INFUSION SETS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DISPLACEMENT AND SELF TESTS PASSED. 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET:| MODEL MMT-398, LOT 8200701