BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2123056 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04117
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS AS WELL AS THE AUDIO BOLUS BUTTON ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. THE AUDIO BOLUS BUTTON WAS FOUND TO BE TORN. A DAMAGED BUTTON COVER WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTON WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED BUTTON SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP AUDIO BOLUS AND BACK LIGHT BUTTONS HAVE STOPPED RESPONDING TO BUTTON PRESSES. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID NOT CLEAN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR