BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 2PK 3ML

    MDR report key: 5197631 · Received November 3, 2015

    Report

    Report Number
    2032227-2015-62210
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    January 26, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    A COMPLETE ANALYSIS AND TESTING OF 11 OPENED AND USED RESERVOIRS, INSPECTED THE RESERVOIRS SNAP CAPS AND SEPTUMS FOR ANOMALIES NONE WERE FOUND. PERFORMED OCCLUSION TEST BY FILLING THE RESERVOIRS WITH DILUENT, CONNECTING TO MEW INFUSION SETS AND CONNECTING TO A MEDTRONIC 7 SERIES INSULIN PUMP, PERFORMED MANUAL PRIME FLUID FLOWED THROUGH THE INFUSION SETS AND OUT OF THE CATHETER TIP CONCLUSION THE RESERVOIRS ARE NOT OCCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT TWO OF THE CUSTOMER'S RESERVOIRS CAUSED NO DELIVERY ALARMS DURING THE MANUAL PRIME PROCESS. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. TROUBLESHOOTING COULD NOT OCCUR FOR THE NO DELIVERY ALARM DUE TO THE CUSTOMER RESOLVING THE ISSUE WITH A RESERVOIR CHANGE PRIOR TO THE PHONE CALL. THE CUSTOMER WAS ADVISED TO CALL WHEN ALARMS OCCUR IN ORDER TO TROUBLESHOOT. THE SUSPECT RESERVOIR WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT RESERVOIR WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729284 RESERVOIR 2PK 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332AT HG0AQ2X

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR