BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    MDR report key: 1211716 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01828
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 580 MG/DL. THE CUSTOMER COMPLAINED OF NAUSEA, VOMITING, CHEST PAIN, SHORTNESS OF BREATH, AND CONFUSION PRIOR TO BEING ADMITTED TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE BASAL RATES WERE PROGRAMMED CORRECTLY. THE TIME ON THE INSULIN PUMP WAS INCORRECT, SO THE CUSTOMER WAS ASSISTED WITH CORRECTING IT. THE PRIME TEST PASSED. THE INITIAL HIGH PRESSURE TEST FAILED. HOWEVER, AFTER CHANGING THE RESERVOIR AND INFUSION SET, THE HIGH PRESSURE TEST PASSED. THE CUSTOMER STATED THAT PREVIOUSLY HE HAD SOME PROBLEM PRIMING AND REWINDING THE INSULIN PUMP, BUT THE INSULIN PUMP NOW APPEARS TO BE FUNCTIONING NORMALLY. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S DIABETES WAS BEING TREATED WITH MANUAL INJECTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715RNAS PRDGM INS SK EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization