BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2072536 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-81131
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING AROUND 40 MG/DL. THE CUSTOMER'S PERCEIVED CAUSE OF EVENT WAS THE ADJUSTMENT HER PHYSICIAN MADE TO THE INSULIN PUMP TWO DAYS PRIOR TO THE HOSPITALIZATION. THE CUSTOMER STATED THAT THE PHYSICIAN HAD CREATED A PATTERN BASAL BUT HAS NOW TOLD HER TO CHANGE IT BACK TO THE STANDARD BASAL. AT THE TIME OF THE REPORT, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization