BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4250938 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52577
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE RESERVOIR 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

    IT WAS REPORTED THAT THE AIR BUBBLES WERE GETTING INTO THE CUSTOMER'S RESERVOIR, FORCING THE PLUNGER OUT FROM THE BACK OF THE RESERVOIRS. THE CUSTOMER HAD FILLED THE RESERVOIR WITH AIR PRIOR TO PUTTING IT INTO THE INSULIN VIAL TO FILL IT UP AND SHE WAS USING INSULIN THAT WAS AT ROOM TEMPERATURE BEFORE STARTING THE CHANGING PROCESS. THE CUSTOMER STATED THERE WAS NO LEAK OR APPARENT DAMAGE TO THE RESERVOIRS. HER BLOOD GLUCOSE WAS 104 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736743 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG02YBD

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR