BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4823052 · Received June 6, 2015

    Report

    Report Number
    3004209178-2015-63309
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SUSTAINED A CRACK BY THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 94 MG/DL. THE CUSTOMER DID NOT KNOW HOW THE DAMAGE HAD OCCURRED, STATING THAT SHE HAD NEVER DROPPED OR BANGED THE DEVICE. SHE STATED THAT THE CRACK WAS ABOUT 2 TO 3 MM ON BOTH SIDES OF THE RESERVOIR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. SHE DECLINED TO DISCONNECT FROM THE INSULIN PUMP AND WAS ADVISED AGAINST USING IT. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY ABOUT A WEEK PRIOR ON 05/12/2015. SHE DID NOT KNOW HER BLOOD GLUCOSE AT THE TIME OF THE EVENT AND DECLINED TROUBLESHOOTING FOR THE ALARM, AS SHE WAS HAVING THE DEVICE REPLACED ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366864 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR