BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4821237 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-62901
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 ALARMED MOTOR ERROR DURING REWIND DUE TO BROKEN MOTOR SLIDE TIP. THE INSULIN PUMP WAS UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS STUCK INSIDE THE INSULIN PUMP BECAUSE IT WAS INSERTED UPSIDE DOWN. THE INSULIN PUMP ALARMED NO RESERVOIR. HIS BLOOD GLUCOSE LEVEL WAS 40 MG/DL. HE TREATED HIS BLOOD GLUCOSE LEVEL WITH JUICE. THE CUSTOMER WAS GOING TO RECEIVE A REPLACEMENT INSULIN PUMP BECAUSE HE COULD NOT REMOVE THE RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366035 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR