BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2233951 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82793
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY AND STOPS WORKING. THE CUSTOMER STATED HS DR FELLS THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER STATED THAT THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER STATED THAT HE WAS EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS STRUCK ON PRIME/REWIND, AND HE LOST THE SETTINGS VERY OFTEN. THE CUSTOMER STATED THAT HE DISCONTINUE USING THE INSULIN PUMP AS ADVISED BY HIS DR. THE CUSTOMER RECEIVED MEDICAL TREATMENT BY MANUAL INJECTIONS DURING HIS DR'S VISIT. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 300 MG/DL. THE CUSTOMER STATED THAT HE CONTINUES SUFFERING FROM HIGH BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention