BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3895477 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86156
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    November 21, 2013
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER SMELLS A STRONG ODOR OF INSULIN. HE DOES NOT SEE CRACKS OR LEAKS IN THE RESERVOIR. CUSTOMER'S PHYSICIAN POINTED OUT THE ODOR. THE RESERVOIR MAY HAVE LEAKED. CUSTOMER REPORTED A BAD MOTORCYCLE ACCIDENT AND HE BROKE HIS HIP. CUSTOMER STATED THAT HE WAS DRINKING AND NOT INSULIN PUMP RELATED. THE INSULIN PUMP HAS BEEN ON AND OFF. CUSTOMER HAD A BENT CANNULA AND HAD A NO DELIVERY ALARM. THE CURRENT BLOOD GLUCOSE READING IS 254 MG/DL. CUSTOMER HAS TREATED WITH INSULIN PUMP. CUSTOMER HAS BEEN VERY ACTIVE. THE INSULIN PUMP WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369880 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization