BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5102136 · Received September 24, 2015

    Report

    Report Number
    2032227-2015-48414
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 UP ARROW BUTTON DID NOT RESPOND DUE TO A FLATTENED BUTTON DOME SWITCH. NO UNLOCKED KEYPAD CONNECTOR ON THE LCD BOARD NOTED. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED KEYPAD ANOMALY. CUSTOMER WAS NOT ABLE TO CHANGE INFUSION SET DUE TO THE ESC BUTTON NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE WAS 280 MG/DL. CUSTOMER DOES NOT KNOW WHAT CAUSED ANOMALY. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631700 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR