BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233839 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49171
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 REPORTED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL; TREATED WITH MANUAL INSULIN INJECTIONS. CUSTOMER REPORTED THAT SHE WOKE UP AND FOUND THE SCREEN ON THE INSULIN PUMP WAS BLANK. CUSTOMER CHANGED THE BATTERY MULTIPLE TIMES AND RECEIVED BATTERY OUT LIMIT ALARMS. CUSTOMER STATED THAT SHE HAS RECEIVED LOW BATTERY ALERTS, AUTO OFF HAD NO DELIVERY ALARMS. CUSTOMER STATED THE BATTERIES WERE OUT OF THE INSULIN PUMP GREATER THAN DURATION ALLOWED. THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE SET CHANGE. CUSTOMER ALSO STATED THAT SHE WAS HAVING TROUBLE READING THE SCREEN BECAUSE IT IS SCRATCHED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715372 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR