BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 3111139 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93412
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    October 25, 2012
    Report Date
    April 19, 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 ONE OPENED AND USED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND.

    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 FATHER THAT CUSTOMER EXPERIENCED A RESERVOIR LEAK IN (B)(6) 2012. THE INSULIN LEAKED PAST BOTH O-RINGS. THE CALLER NOTICED HIGH BLOOD GLUCOSE LEVEL THAT WOULD NOT DECREASE. CALLER STATED THAT THE RESERVOIR APPEARED TO BE IN GOOD CONDITION, NO MISSING COMPONENTS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212825 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR