BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4142096 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33398
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED SHE HAD CALLED EARLIER THAT DAY TO REPORT THE DEVICE WAS ALARMING NO DELIVERY. CUSTOMER STATED IT WAS RESOLVED WITH A COMPLETE SET CHANGE. THE DEVICE LATER ALARMED TWO ADDITIONAL TIMES. CUSTOMER DID ANOTHER SET CHANGE AND THE DEVICE WAS WORKING. CUSTOMER BELIEVES THE ISSUE WAS WITH THE SUPPLIES. CUSTOMER STATED THE CAP DOESN'T STAY ON. CUSTOMER'S BLOOD GLUCOSE WAS 254 MG/DL, ATTEMPTED TO TREAT WITH THE DEVICE. THE RESERVOIR DOES NOT LOCK IT JUST KEEPS SPINNING. AIR WAS NOTED IN THE RESERVOIR IN THE PREVIOUS CALL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621185 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG05NAC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR