BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4103099 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26408
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD RECEIVED THREE NO DELIVERY ALARMS WHILE ATTEMPTING TO DELIVER A BOLUS. THE BLOOD GLUCOSE READING WAS 79 MG/DL. CUSTOMER HAD TREATED WITH MANUAL INJECTION. SHE REPORTED THAT THE ISSUE HAD BEEN RESOLVED. SHE REMOVED THE INFUSION SET AND STATED THAT THE CANNULA WAS NOT BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582686 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR