BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1063863 · Received June 19, 2008

    Report

    Report Number
    2531779-2008-00342
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED FOR ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECS AT THE TIME OF RELEASE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP BLACKBOX HISTORY SHOWED ONLY DATA FOR DATES (B)(6) 2011 THROUGH (B)(6) 2011; THE PUMP HISTORY FOR 2008 HAS BEEN OVERWRITTEN DUE TO CONTINUED PATIENT USE. DURING INVESTIGATION, THE PUMP PERFORMED WITHIN SPECIFICATIONS. THE PUMP DELIVERED THE PROGRAMMED BASAL RATES FOR 24 HRS WITHOUT INTERRUPTIONS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE MISCOLORED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP WAS UNRESPONSIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR