BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150201 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-21856
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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

    THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO A FLATTENED DOME BUTTON SWITCH. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO A FLATTENED DOME BUTTON SWITCH. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ERROR ALARM. IT WAS ALSO REPORTED THAT THE BUTTONS ON THE INSULIN PUMP ARE STIFF. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 200 MG/DL. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627446 530G INSULIN PUMP OZO OZO MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR