BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944796 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-90817
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 HER BLOOD GLUCOSE METER WAS NOT FUNCTIONING, AND SHE WAS CONCERNED REGARDING THIS ISSUE. THE CUSTOMER STATED THAT SHE IS OVERSEAS AND HER LAST BLOOD GLUCOSE WAS 54MG/DL. SHE ATE SOME FOODS AND DRANK JUICE TO BRING HER GLUCOSE LEVEL UP. TROUBLESHOOTING COULD NOT BE PERFORMED AS CALLER MENTIONED THAT SHE DOES NOT FEEL THE INSULIN PUMP WAS MALFUNCTIONING. THE CUSTOMER STATED HAVING A HYPOGLYCEMIA EPISODE WHEN SHE WAS AT THE STORE AT THE TIME AND SHE WAS GIVEN A GLUCOSE IV. THEN SHE STATED THAT IN ANOTHER OCCASION SHE WAS AT THE PARK AND THEY GAVE HER A GLUCOSE IV. WHEN SHE CHECKED HER BLOOD GLUCOSE IT WAS 20MG/DL. THE CUSTOMER COULD NOT REMEMBER THE DATES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47843 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 56 YR Required Intervention