BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1912699 · Received November 26, 2010

    Report

    Report Number
    2531779-2010-02564
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS NOT INDICATED FOR USE WITH U500 INSULIN. THE USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE PRIME/REWIND SEQUENCE. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET PRIOR TO INITIATING THE REWIND OF THE MOTOR. THE USER MUST MANUALLY CONFIRM THIS ALERT BEFORE PROCEEDING WITH THE REWIND PROCESS. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HOSPITALIZED DUE TO INADVERTENT INFUSION OF INSULIN ON (B)(6) 2010. F/U INFORMATION FROM THE PT INDICATED THAT HE DID NOT DISCONNECT OR REWIND THE PUMP AND INSERTED A FULL CARTRIDGE OF U500 INSULIN INTO THE PUMP, CAUSING INSULIN TO DISPENSE. THE PT WAS DISCHARGED FROM THE HOSPITAL WEARING THE PUMP ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R