BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2841568 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13824
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUBMITTED (B)(4) 2012 FOLLOW-UP # 1 THE PUMP WAS RETURNED TO ANIMAS AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: TESTING CONFIRMED INTERMITTENT RESPONSES FROM THE CONTRAST BUTTON. KEYPAD IS INTACT. REMOVED KEYPAD AND FOUND CONTAMINATION UNDER ALL CONTACTS. UNRELATED TO THIS COMPLAINT, THE DISPLAY WAS DIM/FADING. WHEN REPLACED WITH A TEST SCREEN, THE DISPLAY RETURNED TO NORMAL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE DISTRIBUTOR CONTACTED ANIMAS AND REPORTED THE CUSTOMER WAS HAVING ISSUE WITH KEYPAD RESPONSIVENESS. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS THE ALLEGED KEYPAD ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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