BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4780701 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57384
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED ONE OPENED/USED RESERVOIR. INSPECTED THE RESERVOIR, SNAP-CAP, AND SEPTUM FOR ANOMALIES, AND NONE WERE FOUND. CONDUCTED TESTING FOR OCCLUSION, AND NO OCCLUSION WAS NOTED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA TELEPHONE CALL THAT THE INSULIN PUMP ALARMED FOR NO DELIVERY OF INSULIN. THE BLOOD GLUCOSE READING WAS 220 MG/DL. THE CUSTOMER REPORTED THAT THE ISSUE HAD BEEN RESOLVED WITH A COMPLETE SET CHANGE. THE ALARM DID NOT OCCUR DURING THE MANUAL PRIME. THE CUSTOMER WAS ADVISED THAT THE RESERVOIR WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326189 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR