BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2925846 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-01050
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 18, 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

    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: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PHYSICAL DAMAGE WAS OBSERVED. DURING TESTING, ALL FO THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE OK, UP AND DOWN BUTTONS ARE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE PATIENT DENIED DAMAGE TO RUBBER KEYPAD BUT TEXTURE HAS CHANGED. THE KEYPAD SYMBOLS WERE WORN. THE PATIENT STATED THAT THERE WAS NO TRAUMA TO EVIDENCE OF MOISTURE TO THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED TO A BELT 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
    31027 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR