BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2032307 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80756
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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. MEDWATCH REPORT 1 OF 2 (INSULIN PUMP): 2032227-2011-00725.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA. THE CUSTOMER STATED THAT HE HAD TREATED HIMSELF THE NIGHT BEFORE, FOR HIGH BLOOD GLUCOSE LEVELS OF 343 MG/DL. THE CUSTOMER STATED THAT HIS WIFE FOUND HIM UNRESPONSIVE AND CALLED THE PARAMEDICS. THE CUSTOMER ALSO STATED THAT HE HAD A NO DELIVERY ALARM DURING MANUAL PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7742671

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization