BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210333 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44702
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM OR BLANK DISPLAY NOTED. DEVICE HAD AN FAILED TEST ALARM DURING SELF TEST DUE TO FAULTY CONNECTOR ON REMOTE FREQUENCY BOARD. NO UNEXPECTED RESETTING NOTED. DEVICE HAD CRACKED DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP HAS BEEN RESETTING ITSELF AND IT IS ALARMING. THE DEVICE HAS SHUT OFF BY ITSELF IN THE MIDDLE OF THE NIGHT. CUSTOMER WOKE UP WITH A BLOOD GLUCOSE OF 659 MG/DL. CUSTOMER HAS RECEIVED EIGHT ALARMS. THE ISSUES HAVE BEEN OCCURRING FOR THE PAST COUPLE OF DAYS. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 64 MG/DL. SHE TREATED WITH BREAKFAST. CUSTOMER STATED WHEN THE DEVICE SHUT OFF IN THE MIDDLE OF THE NIGHT, IT WAS ABOUT FIVE HOURS AFTER A LOW BATTERY ALERT. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693392 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention