BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4000319 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-92803
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP ALARMS NO DELIVERY EVERY TIME SHE PUTS IN A NEW INFUSION SET. THIS HAS ONLY HAPPENED WITH HER MOST RECENT SHIPMENT OF SUPPLIES. SHE HAS GONE THROUGH ONE BOX OF INFUSION SETS IN LESS THAN TWO WEEKS. CUSTOMER'S BLOOD GLUCOSE IS 490 MG/DL. HE TREATED WITH MANUAL INJECTION. DURING TROUBLESHOOTING, THE DEVICE ALARMED NO DELIVERY DURING A FIXED PRIME AND INSULIN DID NOT EXIT THE TUBING. INSULIN DID EXIT WHEN MANUALLY PUSHED WITH THE PLUNGER. THE INSULIN PUMP WAS REWOUND AND INSULIN EXITED DURING THE MANUAL PRIME WITHOUT A NO DELIVERY ALARM. CUSTOMER WAS ADVISED THAT THE ALARM WAS CAUSED BY AN INFUSION SET OR RESERVOIR OCCLUSION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476335 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention