BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4860627 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67661
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    THE HUSBAND REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD A DELIVERY ANOMALY WITH THE INSULIN PUMP. THE HUSBAND STATED THE INSULIN PUMP WAS DELIVERING UNPROGRAMMED 10 UNIT BOLUSES. THE CUSTOMER'S BLOOD GLUCOSE WAS BETWEEN 100 MG/DL AND 170 MG/DL AT THE TIME OF INCIDENT. IT WAS ALSO REPORTED, THE KEYPAD ON THE INSULIN PUMP LOCKED. IT WAS REPORTED, THE SUSPEND FEATURE WAS NOT EFFECTIVE ON THE INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 331 MG/DL. THE HUSBAND REPORTED, THE CUSTOMER WAS A BRITTLE DIABETIC. IT WAS ALSO REPORTED, THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE OF 46 MG/DL IN THE PAST. TROUBLESHOOTING FOUND THE INSULIN PUMP PASSED A DISPLACEMENT TEST. CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402724 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other