BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123022 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29537
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. 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).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE TRANSMITTER COULD NOT BE TESTED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP WAS EXPOSED TO WATER, AND SINCE THEN HE HAS HAD ISSUES WITH INACCURATE SENSOR READINGS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. HE STATED THE DEVICE GOT WET IN THE RAIN MONTHS AGO. THERE WAS LIQUID VISIBLE UNDER THE DISPLAY. CUSTOMER TRIED DRYING IT OUT WITH A BLOW DRYER. AFTER A FEW WEEKS, THE MOISTURE SEEMED TO GO AWAY, BUT NOW HIS SENSOR READINGS ARE WIDELY INACCURATE. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600374 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR