BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4962185 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24775
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED FOUR OPEN/USED RESERVOIRS. TESTED THE SNAP-CAP AND SEPTUM FOR ANOMALIES, AND NONE WERE FOUND. RAN OCCLUSION TESTING, AND THE RESERVOIR PASSED. NO OCCLUSIONS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE RECEIVED A NO DELIVERY ALARM DURING MANUAL PRIME. CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT THE TUBING AND RESERVOIR AND PERFORM MANUAL PRIME; INSULIN DID NOT EXIT. THE CUSTOMER HAD CHANGED THE INFUSION SET PRIOR TO CALLING AND; INSULIN DID NOT EXIT THE TUBING AT MANUAL PRIME. CUSTOMER WAS ADVISED TO CHANGE THE RESERVOIR; INSULIN PUMP DID NOT ALARM NO DELIVERY WITH PRIME. CUSTOMER WAS ADVISED THAT CHANGING THE RESERVOIR RESOLVED THE ISSUE. BLOOD GLUCOSE VALUE IS UNKNOWN. IT WAS ALSO MENTIONED THAT A COUPLE OF WEEKS AGO, THE CUSTOMER REMOVED THE RESERVOIR AND HAD BLOOD. THE RESERVOIR WOULD BE REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505025 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG0GDV5

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR