BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4110587 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27443
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 262 MG/DL. THE CUSTOMER REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP DURING PRIME. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPORTED THAT THE RESERVOIR OF THE INSULIN PUMP WAS OCCLUDED. THE CUSTOMER WAS ADVISED THAT THE RESERVOIR OF THE INSULIN PUMP WOULD NEED TO BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590467 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A H9062662

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR