BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920819 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86627
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 CALLER STATED THAT THE CUSTOMER HAS BEEN HAVING HIGH BLOOD GLUCOSE. AT THE TIME OF THE PHONE CALL IT WAS 303 MG/DL. THE CALLER STATED THAT THE CUSTOMER WAKES UP WITH HIGH BLOOD GLUCOSE BUT INSULIN PUMP GOES TO THRESHOLD SUSPEND AND DOES NOT DELIVER INSULIN. THE DRIVE SUPPORT CAP WAS RECESSED, DURING TROUBLESHOOTING IT WAS DISCOVERED THAT THE TUBING WAS KINKED AND THE DEVICE FAILED THE HIGH PRESSURE TEST TWICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398328 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR