BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4242776 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50258
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 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
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH STUCK IN FULL SEGMENT DISPLAY, DUE TO FAULTY CONNECTORS ON INTERFACE BOARD. UNABLE TO VERIFY OFF NO POWER WITH LOW BATTERY INDICATOR ANOMALY, DUE TO FAULTY SENSOR. NO TRACES OF MOISTURE WERE FOUND AT ELECTRONIC OR MOTOR ASSEMBLIES PER VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW.

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE OFF NO POWER AND MOISTURE DAMAGE ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 173 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO POOL WATER. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WILL NOT TURN ON, CANNOT CHECK ALARM HISTORY, AND CANNOT RUN SELF TEST. THE CUSTOMER STATED THE INSULIN PUMP WAS SHUTTING OFF ON ITS OWN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726078 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR