BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103575 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26665
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSULIN KEPT SQUIRTING OUT DURING MANUAL PRIME. CUSTOMER'S BLOOD GLUCOSE WAS 309 MG/DL. CUSTOMER STATED THE INSULIN KEPT DRIPPING AFTER THE MOTOR STOPPED MOVING. CUSTOMER STATED HE WAS NOT SURE IF CUSTOMER TRIED TO DELIVER A BOLUS WHILE IN THE REWIND OR FILL PROCESS. CUSTOMER STATED SHE CANNOT SEE THE BOLUS DELIVERY SCREEN WITH 0 UNITS. CUSTOMER STATED SHE WAS UNABLE TO ESC TO THE STATUS SCREEN. CUSTOMER WAS ADVISED TO REMOVE BATTERY FOR 11 MINUTES. CLEARED ALARMS IN THE DEVICE. CUSTOMER CALLED BACK AND STATED THE DEVICE CONTINUED TO HAVE THE SAME ISSUE. CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN AND DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584473 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR