BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723RNAB PRDGM INS V2.3 BL EN RC

    MDR report key: 1840879 · Received September 17, 2010

    Report

    Report Number
    2032227-2010-82673
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 28, 2010
    Report Date
    August 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH SEIZURE-LIKE SYMPTOMS AND A BLOOD GLUCOSE READING OF 765 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DAILY TOTALS MATCHED WITH THE BOLUS AND BASAL RATE DELIVERY TOTALS. FOUND MULTIPLE NO DELIVERY ALARMS IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723RNAB PRDGM INS V2.3 BL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization