BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3895505 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-86142
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. CHECKED O-RINGS/STOPPER GROOVE FOR ANOMALIES. NONE WERE FOUND. RAN BASAL/BOLUS LEAKING TEST. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR LEAKS PAST THE SECOND O-RING.

    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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED LOW RESERVOIR. INSULIN HAS LEAKED INTO THE RESERVOIR COMPARTMENT. THE BLOOD GLUCOSE READING IS 21.6 MMOL/L. CUSTOMER TREATED WITH INSULIN PUMP. CUSTOMER NOTICED THE LEAK WHEN REMOVING THE RESERVOIR FROM THE INSULIN PUMP. THE INSULIN LEAKED PAST THE O-RINGS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370229 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8962300

    Patients

    Seq Age Sex Outcome Treatment
    1