BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4812992 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61706
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 7, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE DEVICE HAD MINOR SCRATCHES ON THE LCD WINDOW, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, AND 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 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A KEYPAD ANOMALY. THE CUSTOMER STATED THEIR ACT AND ESCAPE BUTTONS WERE NOT RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL. THE CUSTOMER REPORTED EXPOSING THE INSULIN PUMP TO MOISTURE PRIOR TO THE KEYPAD ANOMALY OCCURRING. CUSTOMER DID NOT NOTICE ANY MORE OR FREQUENT ALARMS AFTER THE MOISTURE EXPOSURE. A SELF-TEST COULD NOT BE PERFORMED DURING TROUBLESHOOTING BECAUSE THE KEYPAD WAS UNRESPONSIVE. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355564 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR