BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760784 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11294
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2012- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE AUDIO BOLUS BUTTON COVER WAS INTACT. DURING TESTING, THE AUDIO BOLUS BUTTON WAS RESPONSIVE. NO DEFECT WAS FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTED CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE REPORTER NOTED THAT THERE WAS A HOLE IN THE DOWN ARROW KEYPAD BUTTON AND INDICATED THAT THE RESPONSIVENESS ISSUE WITH THE AUDIO BOLUS BUTTON HAD OCCURRED FIRST. THE REPORTER DENIED ANY EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND CLEANED THE PUMP WITH A DRY CLOTH. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED KEYPAD RESPONSIVENESS ISSUE.

    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 16 YR