BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4111429 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27984
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED THAT FOR HIS JOB CUSTOMER HAS BEEN IN AND OUT OF WATER AND HAS COMPLETELY SUBMERGED HIS DEVICE IN THE WATER. CUSTOMER STATED THE DEVICE DID SEEM TO HAVE ANY ERRORS OR MALFUNCTIONS. CUSTOMER ONLY SAW MOISTURE UNDER THE SCREEN, BUT IT WENT AWAY ON IT OWN. CUSTOMER'S BLOOD GLUCOSE WAS 141 MG/DL. CUSTOMER STATED HE WAS IN THE WATER FOR EIGHT TO NINE HOURS AND FORGOT HE HAD THE DEVICE. CUSTOMER WAS ADVISED TO DISCONNECT AT THE QUICK RELEASE. CUSTOMER STATED THE DEVICE DID NOT ALARM AFTER EXPOSURE, HISTORY WAS REVIEWED AND ONLY A METER ERROR ALARM WAS NOTED. NO BUTTON ERROR ALARMS NOTED. CUSTOMER DID A SELF TEST ON THE DEVICE AND IT PASSED. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590507 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR