BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2761095 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11311
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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: THE AUDIO BOLUS BUTTON WAS TORN. A DAMAGED BUTTON WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACT AND IMPACT THE BUTTON FUNCTION. DURING TESTING, THE AUDIO BOLUS BUTTON RESPONDED PROPERLY TO USER PRESSES. UNRELATED TO THE COMPLAINT, ALL THE KEYPAD BUTTONS WERE RESPONSIVE AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS AND REPORTED THAT THE AUDIO BOLUS BUTTON WAS INTERMITTENTLY UNRESPONSIVE. REPORTEDLY, THE AUDIO BOLUS BUTTON WAS CRACKED AND TORN. THE PATIENT INDICATED THAT THE TACTILE CHANGES OCCURRED PRIOR TO THE DAMAGE. THE PATIENT DENIED EVIDENCE OF MOISTURE IN 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 58 YR