BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920003 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86488
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DISPLAY SCREEN ON HER INSULIN PUMP'S DISPLAY SCREEN WAS CHANGING COLORS WITH BLACK SPOTS IN CERTAIN AREAS AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT SHE HAD BEEN HOSPITALIZED FOR AN INFECTION IN HER LEG THREE WEEKS PRIOR. DUE TO THE INFECTION, HER BLOOD GLUCOSE LEVELS ELEVATED ABOVE 400 MG/DL. CUSTOMER STATED SHE HAD ALREADY CHANGED THE BATTERIES IN THE DEVICE AND THAT IT HAD NOT RESOLVED THE ISSUE. ATTEMPTED TO TROUBLESHOOT DEVICE, BUT CUSTOMER DECLINED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 178 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396177 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization