BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190522 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41076
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH SOME COSMETIC DAMAGE.

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING MOTOR ISSUES WITH HIS INSULIN PUMP. AT THE TIME OF REPORTING, HIS BLOOD GLUCOSE LEVEL WAS 400MG/DL, WHICH HE TREATED WITH A MANUAL INJECTION. HE REPORTED GETTING THE MOTOR ERROR ALARM SHORTLY AFTER RECEIVING A NO DELIVERY ALARM. HE WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO HIS BACKUP PLAN. IN ADDITION HE WAS TOLD HIS INSULIN PUMP WOULD BE RETURNED REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668314 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other