BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4854851 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66595
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 30, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE RECENTLY KNOCKED TWO INFUSION SETS OUT OF HER STOMACH. THE CUSTOMER REPORTED CHANGING THE INFUSION SET, BUT NOT THE RESERVOIR. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 235 MG/DL. THE CUSTOMER ALSO REPORTED THAT THERE WAS A GAP IN THE RESERVOIR TUBE AND AN AIR BUBBLE WAS VISIBLE. CUSTOMER STATED THAT ALL OF THE INSULIN PROGRAMMED WAS NOT DELIVERED. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 323 MG/DL. THE CUSTOMER WILL NOT RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398538 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG0DNBC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR