BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3833496 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85016
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL. THE REPORT WAS MADE BY THE MOTHER OF THE CUSTOMER AND SHE STATED THAT THE CUSTOMER'S INSULIN PUMP HAD A MOTOR ERROR ALARM. THE MOTHER REPORTED THAT SHE CHANGED EVERYTHING OUT BUT THE CUSTOMER DID NOT RECEIVE A BOLUS, WHICH LEAD TO THE HOSPITALIZATION. IT WAS REPORTED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT BECAUSE THE MOTHER TOOK OFF THE PUMP AND TREATED WITH MANUAL INJECTION OF INSULIN BEFORE TAKING THE CUSTOMER TO THE EMERGENCY ROOM. THE CUSTOMER COMPLAINED OF VOMITING AND LEG CRAMPS. THE DOCTOR STATED THAT THE CAUSE OF THE ADMISSION WAS DEHYDRATION. THE HOSPITAL TREATED THE CUSTOMER WITH IV AND INSULIN. THE MOTHER ALSO REPORTED THAT DURING TROUBLESHOOTING, IN THE HISTORY OF THE INSULIN PUMP, SHE FOUND THAT HER SON WAS NOT BOLUSING ENOUGH. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 139 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310354 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization