BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1832056 · Received September 8, 2010

    Report

    Report Number
    2531779-2010-01207
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 8, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT INADVERTENTLY ADMINISTERED EXCESS INSULIN BY PRIMING WHILE ATTACHED TO THE INFUSION SET. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING IT. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE PRIME / REWIND SEQUENCE. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRIMED THE PUMP MULTIPLE TIMES WHILE ATTACHED. THE PATIENT EXPERIENCED HYPOGLYCEMIA THAT REQUIRED TREATMENT FROM PARAMEDICS AND EMERGENCY ROOM PERSONNEL. THE LOWEST REPORTED BLOOD GLUCOSE VALUE WAS 60 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization