BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2902256 · Received January 8, 2013

    Report

    Report Number
    2032227-2013-00062
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    THE CUSTOMER CALLED TO REPORT THAT SHE WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE READING OF 657 MG/DL. THE CUSTOMER STATED THAT SHE HAD GLUCOSE IN HER URINE, BUT DID NOT GO INTO DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT HER DOCTOR DID NOT KNOW WHAT CAUSED HER TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT THE ACTIVE INSULIN TIME WAS PROGRAMMED TO 6 HOURS, BUT IT SHOULD'VE BEEN AT 4 HOURS. THE CUSTOMER ALSO STATED THAT SHE WAS ABLE TO PROGRAM SEVERAL BOLUSES, AND FEELS THAT THE INSULIN PUMP SHOULD'VE WARNED HER ABOUT DELIVERING SO MANY. THE CUSTOMER STATED THAT SHE IS CURRENTLY ON STEROIDS, WHICH MAY HAVE CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE IS NOT CURRENTLY USING THE INSULIN PUMP AS IT HAS BEEN ALARMING BATTERY OUT LIMIT. EXPLAINED THE ALARM TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9653 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization