BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933091 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86892
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT HIS INSULIN KEEPS ALARMING NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 146 MG/DL. CUSTOMER CHANGED INFUSION SET AND RESERVOIR AND REWOUND THE DEVICE, BUT IT STILL ALARMS NO DELIVERY. THE ALARM OCCURS DURING MANUAL PRIME. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE FOR TROUBLE SHOOTING. INSULIN EXITED THE TUBING WHEN MANUALLY PUSHED. WHEN CUSTOMER TRIED TO RUN A MANUAL PRIME, THE DEVICE ALARMED NO DELIVERY. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE OF IT AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411174 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR