BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190968 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41214
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED THAT SHE DID NOT DROP THE INSULIN PUMP AND WAS GIVING BOLUS AND THE ACT BUTTON WAS NOT WORKING. CUSTOMER STATED THAT THE ACT BUTTON WAS WORKING ON AND OFF. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL AT THE TIME OF THE EVENT AND CURRENT BLOOD GLUCOSE WAS 1550 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669033 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR