BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2810328 · Received October 31, 2012

    Report

    Report Number
    2032227-2012-07589
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 HE WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE LEVELS IN THE RANGE OF 30 MG/DL. THE CUSTOMER STATED THAT HE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS FOR A FEW WEEKS PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE FIXED PRIME WAS SET TO 3.0, NOT 0.3. ASSISTED IN PROGRAMMING THE CORRECT AMOUNT. ADVISED TO ALSO REVIEW THE BASAL RATE SETTINGS WITH HIS HCP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MDS MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization