BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    MDR report key: 1902390 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83318
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 700 MG/DL. THE CUSTOMER STATED THAT SHE ATTEMPTED TO CHANGE THE SET, SITE LOCATION, AND INSULIN TO RESOLVE THE HIGH GLUCOSE. THE CUSTOMER STATED THAT SHE DID NOT TREAT HER BLOOD GLUCOSE WITH MANUAL INJECTIONS DURING THIS TIME. TROUBLESHOOTING WAS PERFORMED. ALL THE SETTINGS WERE CORRECT. THE DOCTOR REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAL PRDGM INSULIN CLEAR EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization