BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3933261 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86980
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. 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.

    Additional Manufacturer Narrative · 1

    EVALUATED TWO OPENED AND USED RESERVOIRS. INSPECTED RESERVOIRS, SNAP-CAP AND SEPTUM FOR ANOMALIES. NONE WERE FOUND. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATION. NO OCCLUSION FOUND.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT SHE JUST DID A COMPLETE INFUSION SET CHANGE AND NOW HER INSULIN PUMP IS ALARMING NO DELIVERY. WHILE PRIMING THE TUBE, THE DEVICE STOPPED AT 2.4 UNITS. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 300 MG/DL. SHE HAS NOT TREATED YET BECAUSE SHE IS TROUBLE SHOOTING THE DEVICE. INSULIN DID NOT EXIT THE TUBING WHEN CUSTOMER MANUALLY PUSHED THE PLUNGER. HE USED A NEW INFUSION SET WITH THE SAME RESERVOIR, AND INSULIN EXITED THE TUBING. THE DEVICE WAS REWOUND AND CUSTOMER RAN A FIVE UNIT PRIME. THERE WAS NO ALARM. CUSTOMER IS RETURNING INFUSION SET AND RESERVOIR FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409333 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR