BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193639 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41335
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. (B)(4).

    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. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN OFF THE INSULIN PUMP FOR OVER A YEAR. CUSTOMER HAS BEEN BACK ON IT FOR 2 WEEKS AND IS HAVING PROBLEMS. CUSTOMER STATED THAT LAST NIGHT HER BLOOD GLUCOSE LEVEL WENT OVER 600 MG/DL AND THIS WAS THE SECOND TIME THAT IT HAPPENED. CUSTOMER'S HEALTH CARE PROFESSIONAL STATED THAT IT IS UNLIKELY AND JUST UPLOADED THE NUMBERS. CUSTOMER STATED THAT THE SUPPLIES ARE EXPIRED, BUT THE INSULIN IS GOOD. CUSTOMER CHANGED OUT THE SET THAT WAS IN HER BODY. CUSTOMER STATED THAT HER CONCERN WAS THAT EVEN AFTER TREATMENT WITH INSULIN EVERY 30 MINUTES, HER BLOOD GLUCOSE LEVELS KEPT GOING UP. CUSTOMER WAS GIVEN A GLUCOMETER BY HER HEALTH CARE PROFESSIONAL TO UPLOAD. CUSTOMER PERFORMED THE HIGH PRESSURE TEST AND THE PUMP PASSED. INSULIN PUMP WILL NEED TO BE REPLACED AS A COURTESY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672596 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 64 YR