BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090403 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23105
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS INSULIN PUMP WENT COMPLETELY BLANK. HE REPLACED THE BATTERY THREE TIMES BUT THE ISSUE PERSISTS. CUSTOMER'S BLOOD GLUCOSE IS 157 MG/DL. THE BATTERY COMPARTMENT OR CAP IS NOT DAMAGED. CUSTOMER STATED THE DEVICE GOT WET IN THE RAIN TWO WEEKS AGO. THE DEVICE WAS UNDER HIS SHIRT. 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
    568585 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR