BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110737 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27932
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SHE WAS WEARING HER INSULIN PUMP. HER BLOOD GLUCOSE DROPPED LOW AND SHE WAS ON THE FLOOR. THE CUSTOMER STATED THAT THE "EMERGENCY SYSTEM WHEN YOU FALL IS SUPPOSED TO GO" BUT FOR THE PAST THREE TIMES, IT HAD NOT DONE THAT. THE CUSTOMER WAS POSSIBLY INDICATING THAT THE THRESHOLD SUSPEND WAS NOT KICKING IN. SHE STATED THAT HER BLOOD GLUCOSE WAS 110 MG/DL. THE CUSTOMER ALSO STATED THE BUTTONS ON THE INSULIN PUMP WERE NOT WORKING CORRECTLY. THE CUSTOMER FURTHER MENTIONED THAT HER VERTIGO HAD SOMETHING TO DO WITH HER PASSING OUT AND HER BLOOD GLUCOSE WAS 99 MG/DL. A LOW RESERVOIR ALARM WAS RECEIVED. THE CUSTOMER WAS ASSISTED WITH PROGRAMMING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590794 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR