BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4090399 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23097
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    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 SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE WEARING THE INSULIN PUMP, HIS BLOOD GLUCOSE LEVEL CONTINUED TO RISE. CUSTOMER REPORTED THAT HE NEVER RECEIVED A NO DELIVERY ALARM. CUSTOMER STATED THAT HE REMOVED THE RESERVOIR AND NOTICED THAT INSULIN HAD LEAKED OUT INTO THE RESERVOIR COMPARTMENT. CUSTOMER REPORTED THAT THIS WAS THE SECOND TIME HE HAD NOTICED A LEAK. BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568254 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H8605569

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR