BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2002546 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80440
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING SICK FOR THE PAST FEW DAYS AND WENT TO SEE HER DOCTOR THE DAY BEFORE. THE CUSTOMER STATED THAT THE DOCTOR RECOMMENDED INCREASING THE BASAL RATES. THE CUSTOMER STATED THAT HER GLUCOSE WAS ABOUT 200MG/DL ALL DAY AND TREATED WITH A MANUAL INJECTION TWENTY MINUTES BEFORE CALLING. THE CUSTOMER THEN CHECKED HER BLOOD GLUCOSE AND IT WAS READING 303 MG/DL. ADVISED THE CUSTOMER TO CONTACT HER DOCTOR OR GO TO THE EMERGENCY ROOM TO BE TREATED. INSTRUCTED CUSTOMER TO CALL BACK FOR FURTHER QUESTIONS OR CONCERNS. NO FURTHER INFORMATION WAS PROVIDED.

    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 31 YR Required Intervention