BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221759 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46710
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT AND FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 44 MG/DL. CUSTOMER STATED HIS DOCTOR HAD HIM ON NEW MEDICATION. CUSTOMER STATED THAT THE BATTERIES WERE OUT OF THE INSULIN PUMP GREATER THAN THE DURATION ALLOWED. DURING THE BATTERY OUT LIMIT TROUBLESHOOT, CUSTOMER GOT FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS 100 MG/DL. AFTER TROUBLESHOOTING THE INSULIN DID NOT ALARM FAILED BATTERY TEST. ADVISED THE CUSTOMER THAT BATTERY CAP WOULD BE REPLACED TO RULE OUT ANY POSSIBLE ISSUE WITH THE BATTERY CAP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703322 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR