BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4162021 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36063
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. INSULIN PUMP PASSED SELF-TEST AND DISPLACEMENT TEST. NO ALARMS WERE NOTED. INSULIN PUMP HAD MOISTURE DOTS ON THE DISPLAY WHERE IT TURNS ON. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN PUMP DISPLAYED A BLANK SCREEN. CUSTOMER STATED THE PUMP WAS EXPOSED TO EXTREME TEMPERATURES. CUSTOMER'S BLOOD GLUCOSE READING WAS 160 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644397 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR