BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4822242 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-62966
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 17, 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
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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 CALLED AND REPORTED THE INSULIN PUMP WENT DEAD AND HE TRIED FOUR DIFFERENT NEW BATTERIES. CUSTOMER'S BLOOD GLUCOSE WAS 68 MG/DL. CUSTOMER TREATED BY EATING. THE INSULIN PUMP WAS NOT BUMPED, DROPPED, OR EXPOSED TO MOISTURE. THE BATTERY CAP CONTACTS WERE NOT MISSING OR DAMAGED AND NO OTHER RELEVANT CORROSION OR DAMAGE WAS NOTED. FOLLOWING ADVICE TO REMOVE BATTERY FOR 10 MINUTES AND REINSERT THE NEW BATTERY, CUSTOMER STATED THE DISPLAY DID NOT RETURN. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. CUSTOMER WAS FURTHER ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364130 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR