BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4183034 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40011
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    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. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RESERVOIR HAD AIR BUBBLE. CUSTOMER STATED THAT SHE HAVING A HARD TIME PURGING THE AIR BUBBLES OUT OF THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE WAS 187 MG/DL. ADVISED THE CUSTOMER TO PURGE THE AIR BUBBLES AND ADVISED THAT TINY LITTLE AIR BUBBLES IS FINE AS LONG AS THEY DO NOT MOVE WHEN YOU FLICK THE VIAL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662231 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG064K9

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR