BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4191271 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41549
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER BELIEVED THAT SOMETHING WAS WRONG WITH HER INSULIN PUMP DUE TO HAVING HIGH BLOOD GLUCOSE READINGS AND AIR BUBBLES. HER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF REPORTING, BUT SHE STATED THAT HER HIGHS HAD BEEN RANGING BETWEEN 234MG/DL AND 295MG/DL. SHE FURTHER REPORTED THAT HER LAST INFUSION SET HAD A BENT CANNULA, WHICH MAY HAVE CAUSED THE BUBBLES. SHE DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. NO EQUIPMENT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669466 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR