BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211890 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95448
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    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 CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE OF 26MG/DL. THE CALLER STATED THAT THE INSULIN PUMP OVER DELIVERED INSULIN. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVEL INCREASED WHILE STAYING IN THE EMERGENCY ROOM, AND THEY PLACED BACK THE INSULIN PUMP, BUT FORTY FIVE MINUTES LATER HER GLUCOSE LEVEL DROPPED TO 70MG/DL. THE CUSTOMER STATED THAT SHE IS UNABLE TO EAT ENOUGH TO KEEP HER BLOOD GLUCOSE UP WITHOUT BOLUSING. TROUBLESHOOTING WAS PERFORMED, AND BASAL RATES WERE CORRECT AS WELL THE DAILY TOTALS WERE CORRECT. THE CALLER STATED THAT HER INSULIN PUMP MAY HAVE BEEN EXPOSED TO AN X-RAY THE NIGH BEFORE, BUT SHE WAS NOT SURE IF THE DEVICE WAS STILL CONNECTED OR NOT WHEN SHE HAD THE X-RAY DONE. THE DISPLACEMENT TEST WAS PERFORMED AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309336 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization