BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090389 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23076
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 600 MG/DL. THE MOTHER STATED SHE HAS HAD TO CHANGE OUT THE INFUSTION SITE 3 TIMES IN A WEEK. MOTHER DID NOT UNDERSTAND WHY HER DAUGHTER WAS GETTING HIGH BLOOD GLUCOSE. THE MOTHER HAD SPOKEN TO A HEALTH CARE PROFESSIONAL ABOUT THE HIGH BLOOD GLUCOSE. MOTHER HAD THROWN AWAY THE INFUSION SETS SHE HAD TO CHANGE. ADVISED TO KEEP THE INFUSION SETS IN THE FUTURE FOR ANALYSIS. TROUBLESHOOTING WAS PERFORMED AND NO ANOMALIES WERE NOTED. CUSTOMER'S MOTHER STATED THE BLOOD GLUCOSE HASN'T GONE UP. ADVISED ON THE BEST TIMES TO CALIBRATE. ADVISED TO CHANGE TO CHANGE ENTIRE INFUSION SITE, RESERVOIR, INSULIN AND TREAT AS DIRECTED BY A HEALTH CARE PROFESSIONAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568725 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR