BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3831236 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-85001
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 CALLED IN TO REPORT THAT INSULIN PUMP IS NOT PROVIDING AN AUDIBLE ALARM WHEN INSULIN IS NOT BEING DELIVERED AND THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER ALSO STATED THAT CANNULA LOOKED BLOCKED. THE BLOOD GLUCOSE READING WAS 469 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE DEVICE WAS WORKING PROPERLY. CUSTOMERS BLOOD GLUCOSE LEVEL WAS 169 MG/DL DURING REPORTING. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308779 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR