BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801402 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-12989
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 24, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACK BOX AND HISTORY RECORDED SEVERAL CS 127 ALARMS. CS 127 IS A INCORRECT BATTERY ALARM, AN ILLEGAL AA BATTERY HAS BEEN INSERTED ALARM. INVESTIGATORS POWERED UP PUMP AND IMMEDIATELY WENT TO ALARM SCREEN WITH CS 127 ALARM. REMOVED PUMP FROM CASE AND INSPECTED CIRCUIT BOARDS. THE C38 WAS FOUND TO BE THE CAUSE OF THE INCORRECT BATTERY ALARM. INVESTIGATORS DETERMINED A SINGLE COMPONENT FAILURE. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A SINGLE COMPONENT FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278537 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR