BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2243574 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82838
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 HAVING SEVERAL LOW BATTERY ALARMS IN THE LAST TWO WEEKS. THE CUSTOMER HAD CHANGED THE BATTERY AS RECOMMENDED. DURING THE CALL THE CUSTOMER STATED THAT HE WAS HOSPITALIZED OVER THE WEEKEND DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER WAS UNSURE IF IT WAS DUE TO INSULIN PUMP ISSUES OR INFECTION. TROUBLESHOOTING WAS DECLINED, AND THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. THE CUSTOMER STATED THAT THE INSULIN PUMP SHUT OFF IN THE MIDDLE OF THE NIGHT, AND NO OFF POWER ALARMS SHOWED IN THE ALARM HISTORY. 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-515NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization