BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920025 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86484
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. 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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING AND THE DISPLAY SCREEN IS FROZEN. CUSTOMER ALSO STATED DEVICE BUTTONS ARE UNRESPONSIVE. ADVISED CUSTOMER TO REMOVE BATTERY, WAIT FIVE MINUTES AND REINSERT. CUSTOMER STATED DEVICE BUTTONS WERE PARTIALLY UNRESPONSIVE AND DID NOT ALARM AFTER THE BATTERIES WERE REINSERTED. ALSO, DISPLAY SCREEN WAS STILL FROZEN AND SHOWED NO ADVANCEMENT OF THE TIME. CUSTOMER DECLINED FURTHER TROUBLESHOOTING. BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396490 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR