BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033015 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03479
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED AS EXPECTED. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD. THERE WAS EVIDENCE OF MOISTURE CORROSION OBSERVED INSIDE THE PUMP AND ON THE KEYPAD FLEX CONNECTOR. THE BOLUS BUTTON WAS FOUND TO BE LEAKING. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE OK BUTTON ON THE PATIENT¿S PUMP WILL NOT RESPOND TO PRESSES. THE REPORTER DENIED DAMAGE TO THE KEYPAD AND NO TRAUMA TO THE PUMP. THE REPORTER STATED THAT THERE WAS MOISTURE AROUND AUDIO BOLUS BUTTON OF PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136163 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR