BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3243865 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-95993
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPEN AND USED RESERVOIR PERFORMED MANUAL PRIME AND HIGH-PRESSURE TEST PER SPECIFICATIONS. USING A NEW INFUSION SET ALONG WITH THE INSULIN PUMP, THE RESERVOIR PASSED PER SPECIFICATIONS. NO LEAKAGE ANOMALY NOTED DURING ANALYSIS. INSPECTED O-RINGS ON THE STOPPER GROOVE FOR DEFECTS AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343413 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR