BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3243813 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-96007
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RETURNED WITH DEPLETED BATTERY "ENERGIZER ALKALINE" INSTALLED. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST. UNABLE TO CONFIRM THE ROOT CAUSE DUE TO THE INSULIN PUMP PRESERVATION. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME/FILL ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED WHILE WEARING THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER WAS NOT FEELING WELL AND THE DOCTOR GAVE HIM A MEDICATION FOR HIS UPPER RESPIRATORY INFECTION. THE WIFE STATED THAT SHE DOES NOT WANT TO HAVE THE INSULIN PUMP BACK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343056 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 45 YR Death