BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3123017 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93811
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO CT SCANS AND MRIS. CUSTOMER IS RECEIVING BATTERY ALARMS. CUSTOMER ALSO STATED THAT THERE WAS A HOSPITAL VISIT DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS 436 MG/DL. DISPLACEMENT TEST PASSED. CHECK ALARM HISTORY, LOW RESERVOIR, EMPTY RESERVOIR AND BATTERY OUT ALARMS. ADVISED THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223614 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization