BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4233596 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48624
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED 1 OPENED/USED RESERVOIR. INSPECTED RESERVOIR, SNAP-CAP, AND SEPTUM FOR ANOMALIES AND NONE WERE FOUND. THE RESERVOIR PASSED THE OCCLUSION TEST.

    Additional Manufacturer Narrative · 1

    (B)(4).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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS. CUSTOMER DOES NOT RECALL BLOOD GLUCOSE LEVEL. DEVICE ALSO ALARMED NO DELIVERY AND WAS RESOLVED WITH A COMPLETE SET CHANGE. CUSTOMER'S ALARM HISTORY WAS CHECKED AND IT WAS DETERMINED THE DEVICE ALARMED NO DELIVERY AND NOT MOTOR ERROR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714770 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG04SQP

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR