BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211900 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95468
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. MOTOR PASSED MOTOR TEST. UNABLE TO VERIFY EXCESSIVE NO DELIVERY ALARM DUE TO MOTOR ERROR ALARM. NO BLANK DISPLAY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER INSULIN PUMP SHUT OFF YESTERDAY, AND IT DID NOT GIVE HER ANY INSULIN. THE CUSTOMER ATTEMPTED TO REWIND OR RESUME, BUT THE DEVICE ALARMED NO DELIVERY AND MOTOR ERROR. THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE OF 439MG/DL AND SHE IS GOING TO THE HOSPITAL. THE CALLER STATED THAT SHE COULD NOT GET UP AND HAD A HEADACHE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308729 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 Hospitalization