BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170392 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37930
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER INQUIRED ABOUT THE SAFETY NOTIFICATION ON THE SCROLL WRAP FEATURE ON HIS INSULIN PUMP. THE CUSTOMER STATED HE CAUGHT HIMSELF ACCIDENTALLY DOSING FOR A BOLUS AND BASAL. THE CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM HAD OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS 363 MG/DL. THE CUSTOMER STATED HE WAS ABLE TO COMPLETE THE REWIND SEQUENCE ON HIS INSULIN PUMP. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER ALSO REPORTED RECEIVING A LOW BATTERY AND WEAK BATTERY ALARM. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651231 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR