BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2033942 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80725
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 27. THE CUSTOMER STATED THAT AFTERWARDS, SHE HAS BEEN EXPERIENCING A LOT OF INCIDENCES OF LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO STATED THAT THE DOCTOR REPROGRAMMED HER INSULIN PUMP A FEW WEEKS AFTER THE INCIDENT. THE CUSTOMER THEN STATED THAT SHE USES AN MMT-378 SILHOUETTE INFUSION SET, LOT #640864. PROGRAMMING WAS CHECKED AND THE TIME WAS CORRECTED FOR A 12 HOUR DIFFERENCE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization UNOMEDICAL INSULIN INFUSION SET, MMT-378.