BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1032827 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00673
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WENT TO THE EMERGENCY ROOM TWICE IN THE PAST TWO WEEKS FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 591 MG/DL ON THE SECOND EVENT. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS BEEN HAVING A BLANK SCREEN AND HAS BEEN ALARMING NO DELIVERY DURING BOLUS ATTEMPTS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH THE INSULIN PUMP AND WANTED IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention