BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3062672 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04386
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/30/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2013 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN WAS HEAVILY SCRATCHED AND AFTER THE PUMP POWERED ON, WAS FOUND TO BE DIM AND DISCOLORED. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THERE WAS A LINE THROUGH THE DISPLAY LENS. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS REPORT. THIS REPORT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT COMPLAINT REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166133 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1