BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4200456 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23871
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    CUSTOMER REPORTED AIR BUBBLES IN HER RESERVOIRS. THE ISSUE HAS BEEN GOING ON FOR A LONG TIME. SHE STATED EVERY TIME CHANGES RESERVOIRS, SHE GETS AIR BUBBLES. SHE PRIMES THEM OUT PROPERLY, BUT SHE NOTICES THE BUBBLES DURING BOLUS DELIVERIES. CUSTOMER STATED SOMETIMES THERE IS A BIG AIR BUBBLE THAT PREVENTS INSULIN FROM PASSING THROUGH. CUSTOMER'S BLOOD GLUCOSE IS 453 MG/DL. SHE DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE BECAUSE SHE ALREADY DID IT AT THE DOCTOR'S OFFICE. REPLACEMENT RESERVOIRS WERE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575452 RESERVOIR 3ML FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention