BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4820195 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62769
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO CORRODED AT THE MOTHER BOARD AND LCD BOARD PER VISUAL INSPECTION. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP BECAME WET AND WAS NO LONGER WORKING. THE CUSTOMER EXPLAINED THAT THE INSULIN PUMP HAD FALLEN IN WATER. THE CUSTOMER ATTEMPTED TO MANUALLY RESET THE INSULIN PUMP BUT WAS UNABLE TO. THE CUSTOMER'S SCREEN WAS COMPLETELY BLANK AT THE TIME OF THE CALL. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER CONFIRMED THE ISSUE DID NOT RESULT IN A SERIOUS INJURY OR HOSPITALIZATION. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361182 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR