BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190398 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01870
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECS. THE DELIVERY ACCURACY TEST IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT HER INSULIN PUMP WAS NOT FUNCTIONING, AND THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER STOPPED WEARING THE INSULIN PUMP, AND REVERTED TO MANUAL INJECTIONS. THE CUSTOMER STATED THAT SHE HAD A STROKE WHILE WEARING THE INSULIN PUMP, AND FELT THAT WE SENT HER AN INSULIN PUMP THAT CAN POTENTIALLY KILL HER. THE CUSTOMER WAS VERY UNCOMFORTABLE WITH THE INSULIN PUMP AND ITS SUPPLIES, AND WANTED EVERYTHING REPLACED WITH BRAND NEW PRODUCTS. ADVISED THE CUSTOMER THAT A BRAND NEW INSULIN PUMP AND ITS SUPPLIES WOULD BE SHIPPED TO HER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization MMT-396, LOT 9201608 AND 9200444| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET