BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021591 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-80608
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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 HAS BEEN HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE LEVEL OF 26.9 MMOL/L. THE CUSTOMER'S MOTHER STATED THE CUSTOMER WAS USING AN MMT-399600 INFUSION SET, WITH LOT 2298830, AND AN MMT-326A RESERVOIR WITH LOT H7749653. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE SELF TEST. HOWEVER, NO ALARMS OCCURRED DURING THE FIXED PRIME. 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-522CAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization