BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4122090 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27658
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACK BOX STARTS ON (B)(4) 2014. DUE TO CONTINUOUS USE OF THE PUMP, THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(4) 2011 HAVE BEEN OVERWRITTEN. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWS NO EAW¿S RELATED TO THE COMPLAINT. THE TOTAL DAILY DOSE (TDD) ADDS UP CORRECTLY AND REFLECTS THE USER PROGRAMMED BASAL RATE. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT; INFORMATION FOR THE COMPLAINT IS OVERWRITTEN. THE PUMP IS NOT DETECTING THE CORRECT FORCE. REMOVED COVER AND DISASSEMBLED PUMP; FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATIONS. THERE WAS NO EVIDENCE OF CONTAMINATION FOUND IN FORCE SENSOR HOUSING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE PUMP IS NOT DETECTING CORRECT FORCE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/16/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600719 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70