BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4212447 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43285
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 WAS TRYING TO GIVE A BOLUS WHEN SHE GOT A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 479 MG/DL. CUSTOMER STATED THAT SHE HAS NOT HAD ANY MANUAL INJECTIONS. CUSTOMER DID NOT WANT TO TROUBLESHOOT FOR ANY ISSUES. CUSTOMER STATED THAT SHE HAS CHANGED OUT THE INFUSION SET MULTIPLE TIMES. CUSTOMER THINKS IT IS NOT AN ISSUE WITH THE TUBING AS SHE HAS CHANGED OUT THE SET. CUSTOMER HAS SEEN INSULIN COMING OUT OF THE TUBING. SHE STATES THAT THE BOLUS DOES NOT GO UP VERY HIGH BEFORE SHE GETS THE NO DELIVERY ALARM. CUSTOMER REPORTED THAT SHE WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. CUSTOMER DOES NOT WANT TO RETURN THE SET OR THE RESERVOIR FOR ANALYSIS. CUSTOMER REPORTED THAT THE ALARM DID NOT OCCUR DURING MANUAL PRIME. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO ROTATE SITES AS WELL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680760 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR