BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4122475 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27666
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A LARGE PRIME VOLUME OF 59 UNITS WAS SEEN IN THE BLACK BOX ON (B)(6)2014, AND OCCLUSION ALARMS AND ZERO FORCE LOSS OF PRIME WARNINGS ON (B)(6) 2014. THE PUMP WAS EXERCISED FOR 24 HOURS AT 1 UNIT/HOUR WITHOUT ANY LOSS OF PRIME OR OTHER WARNINGS OBSERVED. THE FORCE SENSOR RESISTANCE READING WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION; THE FORCE SENSOR CALIBRATION CHECK FAILED. EVIDENCE OF MOISTURE WAS OBSERVED UNDERNEATH THE DISPLAY LENS; THE AUDIO WAS NON-FUNCTIONAL AND THE DISPLAY WAS NOT CLEAR, DUE TO MOISTURE DAMAGE. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE CASE SEAL TOWARDS THE GRIP AND A LEAK TEST FOUND A LEAK IN THE DISPLAY LENS SEAL. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED MOISTURE UNDER THE DISPLAY, THE FORCE SENSOR WAS OUT OF CALIBRATION, THE BATTERY COMPARTMENT WAS CRACKED AND THE AUDIO WAS NON-FUNCTIONAL DUE TO MOISTURE DAMAGE. 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
    600638 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR