BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3011657 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-91950
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 246MG/DL, BUT HER BLOOD GLUCOSE HAD BEEN OVER 500MG/DL FOR TWO DAYS. THE CUSTOMER STATED THAT SHE WAS DEHYDRATED, LOOSING HER MEMORY, AND COULD NOT SEE. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE ON THE DEVICE WERE CORRECT. THE CUSTOMER WAS NOT USING THE INSULIN PUMP SINCE THE DAY BEFORE THE EVENT AND WAS ON MANUAL INJECTIONS. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL LOW RESERVOIR AND LOW BATTERY ALARMS. THE CALLER MENTIONED THAT SHE WAS PUT ON ZOFRAN TO HELP HER NAUSEA. THE CUSTOMER STATED THAT THE INSULIN PUMP APPEARS TO BE STUCK ON THE REWIND/PRIME MODE. THE CUSTOMER DID NOT FEEL COMFORTABLE AND REQUESTED THE DEVICE BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113843 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization