BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4993598 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-27290
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 VIA PHONE CALL THAT THEY HAD NO DELIVERY ALARM DURING BASAL/BOLUS/FIXED PRIME. CUSTOMER'S BLOOD GLUCOSE WAS 8.0 MMOL/L. CUSTOMER STATED THAT THE INSULIN DID NOT EXIT. CUSTOMER WAS ADVISED TO REINSERT THE RESERVOIR AND RUAN MANUAL PRIME UNTIL AT LEAST 5.0 UNITS. THE CUSTOMER REPORTED THAT THE INSULIN EXIT WITH MANUAL PRIME. THE CUSTOMER WAS ADVISED THAT THE DEVICE IS WORKING AS DESIGNED. THE CUSTOMER WAS ADVISED THAT THE ALARM WAS CAUSED BY SET/RESERVOIR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525988 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8155541

    Patients

    Seq Age Sex Outcome Treatment
    1