BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAP PRDGM INS PL EN US LN

    MDR report key: 1081813 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01270
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 10, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 320 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME TEST. THE HIGH PRESSURE TEST COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT HAVE THE NECESSARY SUPPLIES. IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED A LOW BATTERY ALARM TWO DAYS PRIOR TO THE EVENT, FOLLOWED BY AN OFF NO POWER ALARM THE DAY PRIOR TO THE EVENT, BUT DID NOT CHANGE THE BATTERY IN THE INSULIN PUMP. IT WAS EXPLAINED TO THE CUSTOMER THAT THE LIKELY CAUSE OF THE HYPERGLYCEMIA WAS THAT THE BATTERY HAD BEEN DEPLETED IN THE INSULIN PUMP, THUS PREVENTING THE DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAP PRDGM INS PL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization