BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3191809 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95132
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH HIGH STOP CURRENT DUE TO BURN AND DAMAGE COMPONENTS ON THE INTERFACE BOARD. THE DEVICE ALARMED DURING THE SELF TEST DUE TO A FAULTY COMPONENT AT RADIO FREQUENCY BOARD. HOWEVER, THE UNIT PASSED THE BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM, AND THE DISPLACEMENT TEST. THE DEVICE WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 303MG/DL. IT WAS STATED THAT HIS BLOOD GLUCOSE WENT UP TO 471MG/DL AND HOURS LATER IT DROPPED TO 223MG/DL, CUSTOMER THEN WENT TO THE HOSPITAL. THEY STABILIZED HIS GLUCOSE LEVEL. HOWEVER, HIS BLOOD GLUCOSE WENT UP TO 431MG/DL AGAIN AND HE WENT BACK TO THE HOSPITAL. THE MOTHER STATED THAT HIS BLOOD GLUCOSE IS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUM A MANUAL PRIME AND THE INSULIN DID EXIT. THE MOTHER DECLINED TO PERFORM FURTHER TESTING SINCE THE ALARM HISTORY REVEALED MULTIPLE ERROR ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290518 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 10 YR Hospitalization