BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143583 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94310
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAD A CAR ACCIDENT WHERE SHE WAS THE DRIVE AND EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER RAN INTO ANOTHER CAR, AND THEN SHE HIT A MAIL BOX. THE NEXT THING SHE REMEMBERS A POLICEMAN WAS GIVING HER GLUCOSE THROUGH A TUBE AND THEN THE AMBULANCE TOOK HER TO THE HOSPITAL. THE CALLER BELIEVES THAT HER BLOOD GLUCOSE WAS 60MG/DL, AND IT WAS 211MG/DL BY THE TIME OF HER ADMISSION. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. RAN THE DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244553 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization