BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1851572 · Received September 27, 2010

    Report

    Report Number
    3004209178-2010-82900
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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

    IT WAS REPORTED THAT THE CUSTOMER FELL IN THE WATER AND THE INSULIN PUMP ALARMED BUTTON ERROR ALARM. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE IS IN THE HOSPITAL FOR A HIP INJURY CAUSED BY THE FALL. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE READING WAS 458MG/DL AT TIME OF THE HOSPITALIZATION. HIS GLUCOSE LEVEL WAS TREATED WITH 10 UNITS AND HIS GLUCOSE LEVEL DROPPED TO 393MG/DL. ADVISED THE CUSTOMER'S GIRLFRIEND THAT A REPLACEMENT OF THE INSULIN PUMP WOULD BE DELIVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization