BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3233327 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-95808
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 THE PARAMEDICS WERE CALLED DUE TO HIGH BLOOD GLUCOSE OVER 400MG/DL. THE CUSTOMER EXPERIENCED CHEST PAIN, TIRED, COULD NOT BREATHE WEAK, LIGHT HEADED, NAUSEA, DRY MOUTH AND HUNGRY. THE CUSTOMER MENTIONED HAVING A BAD COLD. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP FOR DEHYDRATION, AND SHE WAS NOT GIVEN ANYTHING FOR HER BLOOD GLUCOSE. CUSTOMER DECLINED FURTHER TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334839 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention