BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4243120 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50297
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 CUSTOMER'S INSULIN PUMP ALARMED NO DELIVERY SEVERAL TIMES DURING BOLUS AND BASAL DELIVERIES. CUSTOMER'S BLOOD GLUCOSE WAS 24.5 MMOL/L. CUSTOMER TREATED WITH A BOLUS AFTER CHANGING SETS. WHEN CUSTOMER REMOVED THE RESERVOIR, THERE WAS A GEL LIKE SUBSTANCE IN THE RESERVOIR. THE VIAL WAS CLOUDY. DURING THE CALL, CUSTOMER CHANGED OUT THE RESERVOIR WITH A CLEAR ONE. THE DEVICE DID NOT ALARM NO DELIVERY ANYMORE. CUSTOMER'S LAST BLOOD GLUCOSE WAS 17.3 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727284 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG03SUG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention