BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAP PRDGM INS PL EN US LN

    MDR report key: 1780988 · Received July 27, 2010

    Report

    Report Number
    2032227-2010-82032
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS ABOVE 1000 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER'S DOCTOR TOOK HER OFF OF THE INSULIN PUMP THERAPY AFTER SHE WAS HOSPITALIZED, AND HE HAS NOT WANTED TO RISK PUTTING HER BACK ON THE INSULIN PUMP. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    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 27 YR Hospitalization