BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153411 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35149
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THE INSULIN PUMP, FOLLOWED BY A NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. 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 STATED SHE WAS ABLE TO REWIND THE INSULIN PUMP AND WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. THE NO DELIVERY ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630621 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR