BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243988 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50366
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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. (B)(4).

    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. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED A MOTOR ERROR ALARM FROM THE INSULIN PUMP DURING BASAL. TROUBLESHOOTING WAS DONE. IT WAS REPORTED THAT THE CUSTOMER WAS USING THE SENSOR FEATURE OF THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT EXPOSED TO ANY STRONG MAGNETIC FIELD. THE CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE ON THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726231 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR