BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2893093 · Received January 2, 2013

    Report

    Report Number
    2531779-2013-00047
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP # 1 SUBMITTED 04/01/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS:TESTING CONFIRMED UNRESPONSIVE KEYPAD. KEYPAD IS TORN OVER THE OK BUTTON. NONE OF THE KEYPAD BUTTONS RESPOND TO PRESSES. KEYPAD REMOVED; UP ARROW, DOWN ARROW AND OK BUTTON CONTACTS ARE INVERTED NO OTHER DAMAGED/MISALIGNED CONTACTS FOUND, CONTAMINATION FOUND UNDER ALL BUTTON CONTACTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, STATING THAT THE UP ARROW, DOWN ARROW, AND OK KEYPAD BUTTONS REQUIRED HARD PRESSES TO ELICIT A RESPONSE. THE REPORTER NOTED DAMAGE TO THE KEYPAD AND ALLEGED THAT THE RESPONSE ISSUES WITH THE BUTTONS HAD OCCURRED FIRST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR