BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930628 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86813
    Event Type
    Injury
    Date Received
    July 12, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCE HIGH BLOOD GLUCOSE LEVELS THE EVENING PRIOR. THE BLOOD GLUCOSE READING AT THE TIME WAS 563 MG/DL. THE CUSTOMER REPORTED THAT THE CONNECTION AT THE QUICK RELEASE WAS NOT CONNECTED, WHICH MAY HAVE BEEN RELATED TO THE ELEVATED BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 369 MG/DL. SHE COMPLAINED OF FLU-LIKE SYMPTOMS BUT DID NOT CONTACT HER DOCTOR AND TREATED WITH MANUAL INJECTION AND BOLUS INSTEAD. UPON TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, THE CUSTOMER REPORTED THAT SHE DID NOT FIND A LEAK. REMOVAL OF THE INFUSION SET PRIOR TO THE CALL REVEALED THAT THE CANNULA WAS BENT AT A 90 DEGREE ANGLE. THE CUSTOMER ALSO MENTIONED CALIBRATION ISSUES WITH THE SENSOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408752 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR