BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2140451 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81822
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AND PARAMEDICS WERE CALLED OUT. THEN THE CUSTOMER WENT TO HER DOCTOR'S OFFICE WHERE A CARELINK REPORT WAS PRINTED AND REVEALED THAT SHE DID NOT BOLUS FOR TWO DAYS, BUT THE CUSTOMER STATED THAT SHE HAS BOLUSED. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 48MG/DL. THE CUSTOMER'S MOST CURRENT GLUCOSE LEVEL WAS 248MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND TIME WERE CORRECT. THE BOLUS HISTORY SHOWED THAT THERE WAS NO BOLUS HISTORY FOR ONE DAY BECAUSE THE DATE ON THE INSULIN PUMP WAS INCORRECT. THE CUSTOMER WAS TREATING FOR LOW BLOOD GLUCOSE AND MAY BE OVER TREATING CAUSING A HIGH BLOOD. THEN THE CUSTOMER TREATS WITH THE INSULIN PUMP AND HER BLOOD GLUCOSE WENT DOWN. NO FURTHER INFO WAS PROVIDED.

    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-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization