BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2770101 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11688
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 11/05/2012- 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 RETURNED TORN. A DAMAGED BUTTON WILL PERMIT CONTAMINATION TO PERMEATE WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED BOLUS BUTTON SHOULD BE CLEARLY VISIBLE AND PROHIBIT THE USE. DURING TESTING, THE AUDIO BOLUS BUTTON RESPONDED APPROPRIATELY. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS REMOVED AND EVIDENCE OF A MILD WHITE RESIDUE WAS PRESENT UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2012 STATING THAT THE KEYPAD WAS DAMAGED AND THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE DISTRIBUTOR WAS UNABLE TO DETERMINE WHETHER THE DAMAGE OR THE RESPONSIVENESS ISSUES HAD OCCURRED FIRST. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSIVENESS ISSUE.

    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