BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1982289 · Received February 1, 2011

    Report

    Report Number
    3004209178-2011-80274
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE IN THE 400 MG/DL RANGE. THE CUSTOMER DECLINED TO TROUBLESHOOT THE DEVICE AND HE REQUESTED A REPLACEMENT OF THE INSULIN PUMP. THE CUSTOMER SATED THAT HE RECEIVED TREATMENT WHILE AT THE DOCTOR'S OFFICE DURING HIS VISIT, AND HE DID HAVE A BACK UP PLAN. ADVISED THE CUSTOMER THAT A REPLACEMENT OF THE DEVICE WOULD BE SENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization