BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1843435 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-82867
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF OVER 400 MG/DL. THE SPOUSE STATED THAT THE CUSTOMER TREATED HIS BLOOD GLUCOSE WITH A SHOT OF INSULIN AND LAID DOWN. IT WAS STATED THAT A HALF HOUR LATER, HE WOKE UP AND HE WAS HAVING TROUBLE CHECKING HIS GLUCOSE LEVEL. THE WIFE ASSISTED HIM AND THE BLOOD GLUCOSE READING WAS 25 MG/DL. THEN THE PARAMEDICS WERE CALLED AND WHEN THEY ARRIVED THE CUSTOMER'S BLOOD GLUCOSE WAS LESS THAN 20 MG/DL. THE PARAMEDICS GAVE HIM GLUCOSE TABLETS AND TRANSPORTED TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. RAN A HIGH PRESSURE AND DISPLACEMENT TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAB PRDGM INSULIN BLUE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization