BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4850793 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66096
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED RESERVOIR, SNAP-CAP AND SEPTUM FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST PER SPECIFICATIONS, RESERVOIR FILLED AND CONNECTED TO NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO INSULIN PUMP AND PERFORMED INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR TO INSULIN PUMP AND PERFORMED CATHETER TIP. RESERVOIR NOT OCCLUDED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A NO DELIVERY ALARM DURING THE FILL TUBING PROCESS. THE CUSTOMER STATED THAT SHE PREVIOUSLY HAD TO ATTEMPT THIS PROCESS THREE TIMES IN ORDER FOR IT TO WORK. DURING TROUBLESHOOTING, THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME AND THE CUSTOMER WAS UNABLE TO GET INSULIN TO EXIT THE TUBING. BLOOD GLUCOSE LEVEL WAS 96 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS ADVISED THAT THE RESERVOIR WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393055 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG04NBZ

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR