BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3081263 · Received April 26, 2013

    Report

    Report Number
    2032227-2013-01547
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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 THAT SHE EXPERIENCED BLOOD GLUCOSE LEVELS GREATER THAN 300 MG/DL THREE WEEKS AGO. THE CUSTOMER STATED THAT SHE GAVE HERSELF A MANUAL INJECTION, AND ENDED UP IN THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL UNDER 15 MG/DL. THE CUSTOMER THOUGHT THERE MAY HAVE BEEN A KINK IN THE TUBING THAT MAY HAVE GIVEN HER EXTRA INSULIN. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED, BUT THE CUSTOMER DIDN'T KNOW IF THE BASAL RATES WERE CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. ADVISED THE CUSTOMER TO CHECK THE INSULIN PUMP SETTINGS WITH HCP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181136 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization