BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP

    MDR report key: 6126598 · Received November 23, 2016

    Report

    Report Number
    2032227-2016-46013
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WS ADMITTED TO THE HOSPITAL FOR A LOW BLOOD GLUCOSE EVENT. THE PATIENT HAD BEEN HAVING BLOOD GLUCOSE VALUES IN THE 50 MG/DL RANGE. THE CUSTOMER HAD BEEN TREATING HIS LOW BLOOD GLUCOSE EVENTS WITH CANDY. NO FURTHER DETAILS WERE PROVIDED FOR THE HOSPITALIZATION. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777290 630G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization