BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4222132 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-47169
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 (B)(4) 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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED. BLOOD GLUCOSE VALUE STARTED AT 75 MG/DL AND WENT DOWN TO 60 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS SHOWING SHE STILL HAD 20 UNITS OF ACTIVE INSULIN ON BOARD AND BLOOD GLUCOSE LEVEL WAS DROPPING. CUSTOMER CALLED THE DOCTOR AND WAS ADVISED TO GIVE GLUCAGON SHOT AND GO TO THE EMERGENCY ROOM. CUSTOMER GAVE SHOT AND ATE SOME GLUCOSE TABLETS. BLOOD GLUCOSE AT THE TIME OF THE ADMISSION WAS 160 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703626 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization