BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 1993484 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80363
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING LOW BLOOD GLUCOSE OF 30MG/DL. THE CUSTOMER STATED THAT SHE HAD SEIZURES AND PASSED OUT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS TREATED AT HOME BY THE PARAMEDICS. THE CUSTOMER STATED THAT SHE WAS CONNECTED DURING THE REWIND AND MANUAL PRIME OF THE INSULIN PUMP. THE TIME AND DATE WERE CORRECT. THE BASAL AND BOLUS MATCHED TO THE DAILY TOTALS. THE AMOUNT OF INSULIN ON THE SCREEN MATCHED TO THE VISIBLE UNITS LEFT IN THE RESERVOIR. RAN A DISPLACEMENT TEST AND THE DEVICE PASSED THE TEST. ADVISED THE CUSTOMER TO TALK TO HER DOCTOR ABOUT HER LOW BLOOD GLUCOSE. 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 55 YR Required Intervention