BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 889248 · Received August 3, 2007

    Report

    Report Number
    2531779-2007-00415
    Event Type
    Injury
    Date Received
    August 3, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 2, 2007
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. ANIMAS HAS ALSO CONDUCTED AN EVALUATION OF A CARTRIDGE FROM THE MANUFACTURING LOT MOST RECENTLY SHIPPED TO THIS PT (LOT # B201087, EXPIRATION DATE 05/31/08, MANUFACTURE DATE 11/30/06). THE CARTRIDGE WAS OPERATING WITHIN REQUIRED SPECIFICATIONS. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. THE PT REPORTED THAT PRIOR TO THE HOSPITALIZATION, SHE OBSERVED A CRACK IN THE CONNECTION BETWEEN THE CARTRIDGE AND THE INFUSION SET TUBING AND REPLACED THE SET. THE PT ALSO REPORTED THAT THE AUDIO BOLUS BUTTON ON THE PUMP WAS NOT FUNCTIONING PROPERLY, BUT CONFIRMED THAT THE STANDARD KEYPAD COULD BE USED TO DELIVER INSULIN BOLUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization