BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2190323 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82234
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 8, 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, 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 BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE TWO WEEKS AGO. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET THE NIGHT BEFORE THE CALL, AND SHE FILLED THE RESERVOIR WITH 114.0 UNITS OF INSULIN. THE CUSTOMER STATED THAT THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER STATED THAT THE INSULIN PUMP REGISTERED THE BOLUSES AND BASALS CORRECTLY IN THE DAILY TOTALS. THE UNITS REMAINING IN THE STATUS SCREEN MATCHED TO THE UNITS LEFT IN THE RESERVOIR. THE CUSTOMER STATED THAT SHE MAY HAVE OVER BOLUSED TO TREAT HER HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE INSULIN PUMP PASSED THE TEST. THE CUSTOMER MENTIONED WEARING THE INFUSION SET FOR THREE DAYS. THE CUSTOMER STATED THAT SHE IS UNDER NEW MEDICATIONS, BUT HER DOCTOR DID NOT INDICATE WHETHER THE MEDICATIONS WOULD AFFECT HER BLOOD GLUCOSE. NO FURTHER INFO 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 48 YR Hospitalization