BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4120033 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29355
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND SKIN IRRITATION AT THE INFUSION SET INSERTION SITE. THE BLOOD GLUCOSE READING WAS 479 MG/DL ON THE AFTERNOON OF THE CALL, AND AT THE TIME OF THE CALL, THE BLOOD GLUCOSE READING WAS 450 MG/DL. THE CUSTOMER TREATED WITH A MANUAL INJECTION AND CHANGED HER INFUSION SET. SHE DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE SINCE SHE STATED THAT SHE WOULD BE SEEING HER DOCTOR REGARDING THE SKIN IRRITATION AND DID NOT WANT TO CHANGE HER INFUSION SET. SHE DESCRIBED THE INSERTION SITE ON HER SKIN AS A RAISED, RED SPOT WITH A HARD KNOB ON IT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596986 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR