BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842812 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13861
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 2, 2012
    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

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO DAMAGE WAS OBSERVED. THE LETTERING ON THE KEYPAD WAS FOUND TO BE WORN, WHICH HAS NO EFFECT ON INSULIN DELIVERY. DURING TESTING, THE ORIGINAL COMPLAINT OF THE DELAYED RESPONSE IN THE OK KEYPAD BUTTON WAS NOT DUPLICATED OR CONFIRMED. ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE OK BUTTON WAS DELAYED IN RESPONDING. THE PATIENT DENIED DAMAGE TO THE KEYPAD AND NO MOISTURE EXPOSURE. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR