BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4221751 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46704
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 30 MMOL/L. CUSTOMER HAD BOLUSED WITH THE PUMP AND THOUGHT THAT MAYBE HER HANDS WERE NOT CLEAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 7 MMOL/L AT 6 PM, BUT WENT UP TO 25 MMOL/L A FEW HOURS LATER. CUSTOMER RETESTED AND HER BLOOD GLUCOSE LEVEL WAS 22.5 MMOL/L. CUSTOMER REALIZED THAT HER INFUSION TUBE HAD BEEN DISCONNECTED. CUSTOMER HAD NOT EATEN SINCE AND WHEN SHE CHECKED HER BLOOD GLUCOSE LEVEL IT WAS 29.9 MMOL/L. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 25.2 MMOL/L. CUSTOMER TREATED WITH A SET CHANGE AND BOLUS. CUSTOMER DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL FOR THEIR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER TREATED WITH A PEN/NEEDLE. CUSTOMER RAN A MANUAL PRIME AND STATED THAT THE INSULIN DID EXIT THE TUBING. CUSTOMER DID NOT FIND ANY LEAKS IN THE TUBING OR RESERVOIR CONNECTION. CUSTOMER IS NOT COMFORTABLE WITH HER PUMP AND HAS NEVER HAD A BLOOD GLUCOSE LEVEL THIS HIGH. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702502 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG02JKV

    Patients

    Seq Age Sex Outcome Treatment
    1