BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170444 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37793
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    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 BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BUTTON ERROR. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LED TO THE ALARM OR IF THE DEVICE WAS DROPPED, BUT MAY HAVE BEEN EXPOSED TO PERSPIRATION. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 166 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651928 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR