BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1821166 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82454
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. HOWEVER, THE INSULIN PUMP PASSED THE OCCLUSION, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 280 MG/DL AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT HER DOCTOR WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization