BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3130787 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94076
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED THREE OPENED AND USED RESERVOIRS. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. NO LEAKAGE ANOMALIES WERE OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIRS CONNECTED AND LOCKED IN PLACE PROPERLY.

    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 BY CUSTOMER'S WIFE, (B)(6,) THAT THE RESERVOIR LEAKED. CUSTOMER'S BLOOD GLUCOSE READING WAS 378 MG/DL. CUSTOMER TREATED WITH A BOLUS FROM THE INSULIN PUMP. CUSTOMER STATED THAT HE WAS RUNNING HIGH. THE LEAK IS LOCATED AT THE BOTTOM OF THE RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232230 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR