BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4203804 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30128
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOWN ARROW BUTTON DID NOT RESPOND DUE TO CORRODED KEYPAD TRACES. NO FROZEN SCREEN WAS NOTED. THE TIME ADVANCED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SCREEN ON HER INSULIN PUMP IS FROZEN. SHE REPLACED THE BATTERY BUT THE DEVICE WILL NOT DO ANYTHING. CUSTOMER'S BLOOD GLUCOSE IS 368 MG/DL. THE SCREEN IS NOT TOTALLY BLANK. THERE ARE NO ALARMS. CUSTOMER REMOVED THE BATTERY FOR FIVE MINUTES. THERE SCREEN IS STILL FROZEN AND THE TIME HAS NOT CHANGED. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603805 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR