BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3100686 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01761
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    CUSTOMER CALLED TO REPORT MEDICAL TREATMENT FROM EMTS CALLED TO HER HOME FOR LOW BLOOD GLUCOSE. CUSTOMER WAS GIVEN INTRAVENOUS TREATMENT. CUSTOMER STATED THAT SHE HAS EXPERIENCED LOW BLOOD GLUCOSE FOR ABOUT 8 YEARS AND EMTS HAVE COME TO HER HOME MULTIPLE TIMES. DURING TROUBLESHOOTING, PROGRAMMING IS CORRECT. PRIMING TECHNIQUE IS CORRECT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201697 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization