BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAP PRDGM INS V2.1 PL EN

    MDR report key: 1142776 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01483
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT PARAMEDICS WERE CALLED TO REVIVE HER AFTER SHE EXPERIENCED EXTREME LOW BLOOD GLUCOSE LEVELS AND HAD TO PULL OVER TO THE SIDE OF THE FREEWAY. THE REPORTED BLOOD GLUCOSE READING WAS 47 MG/DL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD ALARMED BATTERY OUT LIMIT, AND THE BUTTONS WERE NOT RESPONDING. TROUBLESHOOTING WAS PERFORMED, BUT RESTING THE INSULIN PUMP WITHOUT A BATTERY DID NOT RESOLVE THE ISSUE WITH THE BUTTONS BEING UNRESPONSIVE. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO MANUAL INJECTIONS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention