BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2962570 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00641
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 25, 2012
    Report Date
    January 28, 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 67 MG/DL. CUSTOMER STATED THAT SHE WAS NOT ABLE TO EAT FOR 12 HOURS, DUE TO SHE WAS FASTING FOR A BLOOD GLUCOSE TEST AND SHE PASSED OUT IN THE STREET DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT SHE HAS BEEN HOSPITALIZED SEVERAL TIMES FOR LOW BLOOD GLUCOSE, BUT DOES NOT RECALL THE DATES OF THE PREVIOUS HOSPITALIZATIONS. CUSTOMER ALSO STATED THAT SHE IS CURRENTLY HOSPITALIZED FOR 2 MONTHS, BUT UNRELATED TO DIABETES. SHE STATED THAT HER BLOOD GLUCOSE HAS BEEN HIGH AND FLUCTUATING DURING HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65491 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization