BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1050166 · Received May 23, 2008

    Report

    Report Number
    2032227-2008-00884
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER MENTIONED THAT SHE HAS BEEN HAVING REPEATED NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. NO HIGH PRESSURE TEST WAS PERFORMED, AS THE CUSTOMER ASKED TO HAVE THE INSULIN PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization