BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1791802 · Received August 4, 2010

    Report

    Report Number
    3004209178-2010-82342
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 595 MG/DL. THE CUSTOMER STATED THAT WHEN HE ARRIVED TO THE EMERGENCY ROOM HE NOTICED THAT THE CANNULA WAS BENT. RAN A FIXED PRIME TEST AND THE INSULIN DID NOT EXIT. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WAS CORRECT. THE PROGRAMMING MATCHED AND IT WAS ALSO CORRECT. PERFORM A HIGH PRESSURE TEST AND FAILED. ADVISED CUSTOMER TO REMOVE THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization