BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4250940 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52583
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO SHUT OFF ANOMALY COULD BE VERIFIED DUE TO A BLANK DISPLAY. NO FUNCTIONAL TESTS COULD BE PERFORMED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A SEVERELY CORRODED BATTERY CAP CONTACT. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    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

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP SCREEN WAS BLANK AFTER INSERTING NEW BATTERIES. THE CUSTOMER'S BLOOD GLUCOSE WAS 343 MG/DL, AND SHE TREATED WITH A BOLUS. THE INSULIN PUMP SCREEN TURNED BACK ON WHEN SHE REINSERTED THE BATTERY. IT WAS STATED THAT THE INSULIN PUMP WAS SHUTTING OFF, DESPITE USING A NEW BATTERY CAP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737730 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR