BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760929 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11307
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 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: EVALUATION REVEALED THAT THE KEYPAD SYMBOLS WERE WORN BUT THE RUBBER KEYPAD WAS INTACT. EVALUATION REVEALED THAT THE DOWN AND CONTRAST BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE HARD PRESSES TO ELICIT A RESPONSE. THE UP AND OK BUTTONS RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND STATED THAT THE DOWN ARROW KEYPAD BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. IT WAS INDICATED THAT THE RUBBER KEYPAD WAS VERY THIN OVER THE DOWN ARROW BUTTON AND ALL THE SYMBOLS WERE WORN OFF. THE REPORTER DENIED ANY DAMAGE TO THE RUBBER KEYPAD OR EVIDENCE OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID NOT CLEAN THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED KEYPAD 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 6 YR