BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4122907 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-28775
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE ACT BUTTON DID NOT RESPOND DUE TO A FLATTENED BUTTON DOME SWITCH. NO BATTERY OUT LIMIT ALARM COULD BE VERIFIED DUE TO THE UNRESPONSIVE BUTTONS. NO NUMBER SCROLLING ANOMALY WAS NOTED ON THE DISPLAY. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONICS. 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 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUMBERS ON THE CUSTOMER'S INSULIN PUMP WERE CONTINUOUSLY SCROLLING WHEN SHE WOULD TRY TO DELIVER A BOLUS. SUBSEQUENTLY, THE BUTTONS ON THE KEYPAD STOPPED RESPONDING. THE CUSTOMER'S BLOOD GLUCOSE WAS 123 MG/DL.. THE CUSTOMER STATED THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO PERSPIRATION. SHE WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601165 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR