BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1063290 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01018
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE TWO WEEKS AGO. WHILE ON CALL, THE BLOOD GLUCOSE READING WAS 359 MG/DL. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE ARE UNSTABLE AND FLUCTUATE FROM 33 TO 600 MG/DL IN ONE DAY. TROUBLESHOOTING WAS PERFORMED. FOUND THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND DISPLAYED THE CORRECT AMOUNT OF UNITS LEFT IN THE RESERVOIR. ALSO IT WAS FOUND THAT THE FIXED PRIME TEST WAS SET HIGHER. NO FURTHER INFO WAS PROVIDED. CORRECTED FIXED PRIME AND ADVISED CUSTOMER TO MONITOR HIS BLOOD SUGAR AND TREAT AS NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization