BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2890553 · Received December 31, 2012

    Report

    Report Number
    2531779-2012-15245
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE DOWNLOAD HISTORY DID NOT REVEAL ANY LARGE PRIME AMOUNTS RECORDED. ON TESTING, THE PUMP POWERED ON NORMALLY. EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY. THE FORCE SENSOR CALIBRATION TEST REVEALED THE FORCE SENSOR TO BE OUT OF SPECIFICATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED CONTAMINATION ON THE FORCE SENSOR ASSEMBLY.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION OF THE FORCE SENSOR ASSEMBLY AND THE FORCE SENSOR OUT OF SPECIFICATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR