BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2123361 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81733
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LEAKY RESERVOIR. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER CHANGED HIS INFUSION SET AND RESERVOIR THE NIGHT BEFORE AND THAT THE RESERVOIR WAS FILLED WITH 150 UNITS OF INSULIN. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS AT 401 MG/DL AND THAT HE HAD KETONES IN HIS URINE. SUBSEQUENTLY, THE CUSTOMER'S MOTHER CALLED A DOCTOR FOR TREATMENT ADVICE AND TREATED THE CUSTOMER WITH A MANUAL INJECTION. THE CUSTOMER'S MOTHER THEN STATED THAT THERE WAS THE SMELL OF INSULIN IN THE RESERVOIR CHAMBER BUT THAT THE CHAMBER WAS DRY, ALTHOUGH, THERE WAS A WET SPOT ON THE BED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7701618

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR