BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4160153 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25961
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR RESERVOIR'S PLUNGER DOES NOT MOVE WHEN PUSHED. CUSTOMER STATED THAT WHEN THEY ATTEMPT TO FILL RESERVOIR WITH INSULIN AND THEN FLICK THE RESERVOIR TO RELEASE THE AIR BUBBLES, THE PLUNGER DOES NOT RELEASE THE AIR BUBBLES. ADVISED CUSTOMER ISSUE MAY BE DUE TO THE TRANSFER GUARD. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 85 MG/DL AT TIME OF REPORTING. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581480 RESERVOIR 1.8ML FRN MEDTRONIC MINIMED MMT-326A HG02YBD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR