BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121140 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93746
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 BEING HOSPITALIZED, AND HIS DOCTOR BELIEVES THE INSULIN PUMP HAS BEEN MALFUNCTIONING. THE CUSTOMER STATED THAT HE DID NOT FAINT BUT WAS LETHARGIC AND COULD HARDLY MOVE. WHILE STAYING IN THE HOSPITAL, THE CUSTOMER STATED THAT THE DOCTORS CHECKED HIS HEART AND BRAIN WAVES. HE STATED THAT ONE SIDE OF HIS NERVES DID NOT HAVE FEELINGS. TROUBLESHOOTING WAS PERFORMED, AND THE BASAL RATES, BOLUS WIZARD SETTINGS, AND ALARM HISTORY WERE REVIEWED. ALL THE INSULIN PUMP HISTORY INDICATES THAT THE DEVICE IS FUNCTIONING AS DESIGNED. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS NOT HIGH, AND IT WAS 126MG/DL. HOWEVER, HIS GLUCOSE LEVEL WAS 258MG/DL AT THE HOSPITAL AND HE WAS GIVEN SHOTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221731 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 66 YR Hospitalization