BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933263 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86969
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE LEVELS HAVE BEEN HIGH FOR THE PAST THREE WEEKS. THE BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS 430 MG/DL. FOR THE PAST YEAR, SHE HAS BEEN SWITCHING THE SITE LOCATIONS ON HER BACK FROM SIDE TO SIDE. THE CUSTOMER STATED THAT WHEN SHE RECEIVES THE NEW SUPPLIES THAT SHE WILL SWITCH TO A 6 MM QUICK SERTER AND A 6 MM CANNULA. DURING TROUBLESHOOTING, THE INSULIN PUMP PASSED SUPPORT CAP, REWIND, AND TUBING TESTS. THE CUSTOMER WAS ADVISED TO CALL BACK IF ISSUE PERSISTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409759 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR