BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4182871 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39971
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MOTOR ERROR ALARMS ON THE INSULIN PUMP DURING A BOLUS DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. THE CUSTOMER STATED THAT WHEN SHE RECEIVED THE ALARM, SHE WOULD JUST CLEAR IT, REWIND THE INSULIN PUMP, AND MOVE ON. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MAGNETIC RESONANCE IMAGING MACHINE. THE CUSTOMER USES THE SENSOR FEATURE ON THE INSULIN PUMP. SHE WAS ADVISED THAT A FALSE MOTOR ERROR ALARM COULD BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE INSULIN PUMP DELIVERS A BOLUS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661337 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR