BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233076 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48640
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    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 RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER HIT THE ESC BUTTON AND THE ALARM OCCURRED. CUSTOMER HAS ALSO GOTTEN A SENSOR ERROR. CUSTOMER USES THE SENSOR FEATURE ON THE PUMP. IT WAS EXPLAINED THAT A FALSE MOTOR ERROR MAY BE CAUSED BY VIEWING THE SENSOR GLUCOSE GRAPH WHILE THE PUMP IS DELIVERING A BOLUS. CUSTOMER STATED THAT SHE WAS ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER STATED THAT SHE WAS ABLE TO COMPLETE THE REWIND, BUT SHE IS STUCK IN SUSPEND. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. CUSTOMER WAS ADVISED TO RETURN THE PUMP WITH THE BATTERY AND ZERO OUT THE BASAL RATES. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715453 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR