BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3870934 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85714
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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

    CUSTOMER CALLED IN TO REPORT INSULIN PUMP BUTTONS ARE UNRESPONSIVE AND MAY BE STUCK. CUSTOMER STATES SHE IS UNABLE TO TELL IF DEVICE IS DELIVERING ENOUGH INSULIN. BLOOD GLUCOSE LEVEL WAS 97 MG/DL AT TIME OF REPORTING. CUSTOMER ALSO STATES INSULIN PUMP HAS A CRACK BY THE BATTERY COMPARTMENT. ADVISED CUSTOMER PUMP WILL NEED TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347486 530G INSULIN PUMP OYZ OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR