BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130810 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94098
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. THE INSULIN PUMP PASSED THE BASIC OCCLUSION, DISPLACEMENT TEST AND BOLUS DELIVERY. NO MOTOR ERROR ALARMS OCCURRED DURING TEST. MOTOR TESTED OK. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAS ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE READING IS 245 MG/DL. THE DISPLACEMENT TEST PASSED. CUSTOMER NOTICES THAT THE DRIVE SUPPORT CAP CLICKS WHEN SHE PUSHES ON IT. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231620 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 27 YR