BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2923753 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00900
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 15, 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. 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 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD SYMBOLS WERE WORN AND THE KEYPAD WAS INTACT. THE CONTRAST BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND THE OTHER BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THERE WAS CONTAMINATION UNDER ALL BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY LENS WAS SCRATCHED AND CRACKED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE UP AND DOWN BUTTONS HAD A DELAYED RESPONSE AND THE OK BUTTON WAS UNRESPONSIVE. THE UP, DOWN AND OK BUTTONS REQUIRED HARD PRESSES TO ELICIT A RESPONSE. THE PATIENT STATED THAT THE KEYPAD WAS INTACT. 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
    30006 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR