BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233752 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49206
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 20 MG/DL WHEN EMERGENCY MEDICAL TECHNICIANS ARRIVED TO TAKE THE CUSTOMER TO THE HOSPITAL. THE CUSTOMER STATED THAT SHE WAS IN BED AND FELL OUT OF BED WHEN SHE LOST HER BALANCE DUE TO LOW BLOOD GLUCOSE LEVELS. SHE STATED THAT SHE WOUND UP WITH A BUMP ON HER HEAD, HAD A SCAN DONE, AND NO DAMAGES WERE OBSERVED FROM THE FALL. SHE WAS UNRESPONSIVE LEADING UP TO THE HOSPITALIZATION. SHE STATED THAT THE PERCEIVED CAUSE OF LOW BLOOD GLUCOSE WAS A KINK IN THE INFUSION SET TUBING, WHICH LED HER TO TREAT WITH MANUAL INJECTIONS. SHE NOTED THAT SHE MAY HAVE TREATED WITH TOO MUCH INSULIN. SHE REPORTED THAT SHE HAD NOT HAD ANY ISSUES SINCE THE HOSPITALIZATION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715683 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization