BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972243 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88659
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND STRIPPED BATTERY CAP COIN SLOT.

    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 THAT SHE WAS UNABLE TO REMOVE THE BATTERY CAP FROM THE INSULIN PUMP. THERE WERE NO SIGNIFICANT EVENTS THAT LED UP TO THE EVENT. IN TROUBLESHOOTING, THE PATIENT WAS ADVISED TO ATTEMPT TO REMOVE THE BATTERY CAP WITH A QUARTER AND A SCREW DRIVER. THE CUSTOMER ATTEMPTED TO USE BOTH THESE METHODS BUT WAS STILL UNABLE TO REMOVE THE BATTERY CAP. THE CURRENT BLOOD GLUCOSE LEVEL IS 122 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447625 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR