BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2082208 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03239
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011, WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. ALL KEYPAD BUTTONS RESPONDED DURING INVESTIGATION. THE KEYPAD WAS REMOVED AND THERE WAS NO PROBLEM OBSERVED WITH THE KEY CONTACTS. NO DEFECT WAS FOUND.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE UP ARROW BUTTON IS NOT RESPONDING. HE DENIED ANY HOLES OR TEARS IN THE KEYPAD. THE PUMP WAS NOT EXPOSED TO WATER.

    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 47 YR