BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1912723 · Received November 23, 2010

    Report

    Report Number
    2032227-2010-83249
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT REWINDING COMPLETELY. THE CUSTOMER STATED THAT SHE FORCED THE RESERVOIR INTO THE DEVICE AND RECEIVED 100 UNITS OF UNWANTED INSULIN. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND DID RECEIVE MEDICAL ATTENTION FOR HER LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO REWIND THE INSULIN PUMP, AND THE DEVICE APPEARED TO REWIND TOTALLY. THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization