BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3051726 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92501
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 REPORTED BEING IN THE HOSPITAL FOR A FEW MONTHS AND REQUESTED ASSISTANCE TO GET BACK ON THE INSULIN PUMP. THE CALLER STATED THAT SHE HAD THE BATTERY OUT FOR ALMOST TWO MONTHS AND THE DEVICE IS ALARMING. DURING THE CALL, THE CUSTOMER STATED THAT SHE HAD KNEE SURGERY, AND SHE BELIEVES BEING IN THE HOSPITAL WITH LOW BLOOD GLUCOSE OF 33MG/DL. THE CUSTOMER WAS INTUBATED AND SHE IS UNSURE ABOUT THE DATES. THE CALLER STATED THAT SHE HAD PNEUMONIA AND CONGESTIVE HEART FAILURE AND WAS NOT ABLE TO MANAGE THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153937 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization