BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4121095 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-21956
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. CUSTOMERS STATED THAT THE NUMBERS ARE JUST SCROLLING BY THEMSELVES. CUSTOMER'S BLOOD GLUCOSE WAS 282 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601546 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR