BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2931834 · Received January 28, 2013

    Report

    Report Number
    2032227-2013-00362
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 STATED THAT SHE WAS IN THE HOSPITAL FOR DIABETES RELATED ISSUES, AND NEEDED ASSISTANCE IN PROGRAMMING THE BASAL RATES TO HALF OF THE CURRENT AMOUNT DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS DROPPED TO 40 MG/DL YESTERDAY, AND SHE ALMOST PASSED OUT. THE CUSTOMER DID NOT KNOW HOW TO CUT THE CURRENT BASAL RATE AMOUNT IN HALF, AND WANTED THE TECHNICIAN TO GIVE HER THE AMOUNTS. THE CUSTOMER WAS TOLD THAT MEDICAL ADVICE CANNOT BE GIVEN, BUT ASSISTANCE COULD BE PROVIDED AS LONG AS SHE PROVIDED THE BASAL RATE AMOUNTS. THE CUSTOMER BECAME UPSET, AND ENDED THE CALL. THE CUSTOMER LATER CALLED WITH THE AMOUNTS, AND WAS ASSISTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37907 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization