BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193666 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41427
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. HOWEVER, THE INSULIN PUMP HAD SMALL CRACKS ON THE BATTERY TUBE THREADS.

    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

    CUSTOMER REPORTED A MOTOR ERROR ALARM DURING A BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 206 MG/DL. SHE ALSO STATED SHE WAS ABLE TO COMPLETE THE REWIND SEQUENCE ON HER INSULIN PUMP. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671549 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR