BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2101569 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-81560
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER USES A QUICK-SET INFUSION SET AND LAST CHANGED HER INFUSION SET THE DAY OF THE EVENT. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER HAS BEEN GETTING NO DELIVERY ALARMS DURING ATTEMPTED BOLUSES AND BASAL RATES. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME AND HIGH PRESSURE TESTS. 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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET:| MODEL MMT-399