BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4122988 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29524
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INSULIN PUMP ALERTED MAXIMUM DELIVERY AND THE CUSTOMER WAS UNABLE TO TREAT HIGH BLOOD GLUCOSE DUE TO THE ERROR MESSAGE. THE BLOOD GLUCOSE READING WAS 407 MG/DL. THE CUSTOMER NOTED THAT SHE HAD HIGH BLOOD GLUCOSE BECAUSE THE INSULIN PUMP WAS NOT DELIVERING INSULIN; ADVISED THAT SHE HAD TAKEN MORE INSULIN THAN EXPECTED ON THE MAXIMUM BOLUS AND BASAL RATES. SHE DECLINED A CALL TO EMERGENCY SERVICES TO ASSIST HER WITH USING THE DEVICE AFTER SHE EXPRESSED FRUSTRATION WITH USING THE INSULIN PUMP. SHE ALSO NOTED THAT SHE HAS GARRISON SYNDROME, IN WHICH SHE DID NOT HAVE ANY TASTE OR SMELL AND EXPERIENCED WEIGHT LOSS. SHE WENT FROM 316 TO 129 LBS IN THE MATTER OF 6 MONTHS. THE CUSTOMER'S HUSBAND ASSISTED WITH TURNING OFF THE BLOCK FEATURE AND WAS ABLE TO GET INSULIN TO EXIT THE TUBING. THE INSULIN PUMP ALARMED BATTERY OUT LIMIT; ADVISED A REPLACEMENT BATTERY CAP WOULD BE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600844 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR