BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234073 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82732
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 TOT HE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE FOR THE PAST WEEK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 220MG/DL. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN PASSED THE TEST. THE HIGH PRESSURE TEST WAS NOT PERFORMED AT THE TIME AND IT WILL BE SENT TO THE CUSTOMER. TWO DAYS LATER THE CUSTOMER CALLED BACK AND STATED THAT SHE STILL IS HAVING ISSUES WITH HER BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE WOKE UP WITH 330MG/DL. THE CUSTOMER TOOK A MANUAL INJECTION AND HER GLUCOSE LEVEL DROPPED TO 152MG/DL. THE CUSTOMER STATED THAT SHE IS IN HER WAY TO THE CLINIC TO BE ASSISTED WITH HER BLOOD GLUCOSE AND THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE WILL CALL BACK UPON HER RETURN FROM THE CLINIC. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention PARADIGM 43", 9MM CATHETER| UNOMEDICAL INFUSION SET: (B)(4), QUICK-SET