BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAB PRDGM INS BL EN ML

    MDR report key: 1873109 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82975
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 565 MG/DL. THE CUSTOMER STATED THAT SHE WAS GETTING NO DELIVERY ALARMS PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP DID NOT DELIVER INSULIN DURING THE PRIME TEST. THE CUSTOMER DID DECLINE FURTHER TROUBLESHOOTING, AND ASKED FOR A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization