BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241226 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50080
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE HAS BEEN HAVING BATTERY CONNECTION ISSUES ON HIS INSULIN PUMP SINCE ABOUT (B)(6) 2014. HE HAS RECEIVED BATTERY OUT LIMIT, OFF NO POWER, AND NO DELIVERY ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT YESTERDAY HE SAW ONE OF THE BATTERY CONTACTS WAS MISSING. THE DEVICE IS WORKING FINE NOW SO CUSTOMER DID NOT WANT TO REPLACE THE BATTERY. A REPLACEMENT BATTERY CAP WAS SENT. CUSTOMER WAS ADVISED OF THE POSSIBLE CAUSES OF BATTERY OUT LIMIT, OFF NO POWER, AND NO DELIVERY ALARMS. HE WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK WHEN NEEDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724067 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR