BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895781 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18384
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX FOUND THE REPORTED CALL SERVICE ALARM ON THE EVENT DATE. MOISTURE WAS EVIDENT IN THE DISPLAY. A LEAK TEST FOUND A LEAK ON THE DISPLAY LENS. THE PUMP POWERED ON WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. THE PUMP ALARMED FOR MOTOR REWIND ERROR DURING THE REWIND/LOAD/PRIME SEQUENCE AND THE 24-HOUR PUMP EXERCISE WAS NOT PERFORMED DUE TO THE ALARM. RELATED TO THE REPORTED ALARM, WHEN THE PUMP CASING WAS OPENED, EVIDENCE OF MOISTURE INTRUSION WAS FOUND ON THE MOTOR CONNECTOR WIRE. THE REPORTED CALL SERVICE ALARM ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371010 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR