BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982304 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06147
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    CUSTOMER'S WIFE REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL FOR PNEUMONIA. SHE STATED THAT HIS BLOOD GLUCOSE DROPPED WHEN HE WAS IN THE URGENT CARE, HE WAS TREATED WITH COOKIES AND JUICE BUT THEY STILL NEEDED TO CALL PARAMEDICS FOR HIM. SHE STATED THAT THE BLOOD GLUCOSE FLUCTUATED BETWEEN LOW AND AS HIGH AS 300 MG/DL. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT, BUT IT WAS REMOVED. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF ADMISSION WAS 187 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457341 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization