BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2220963 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06136
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING NORMALLY TO BUTTON PRESSES WITHOUT DELAY. THE KEYPAD WAS REMOVED AND NO BUTTON CONTACT DEFECTS WERE FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM WITH A REDDISH TINT AND THE BATTERY CAP WAS FOUND TO BE STRIPPED. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, THE OK BUTTON WILL INTERMITTENTLY RESPOND TO USER INPUT. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. THE PATIENT WILL GO ON THE BACKUP PLAN AS NEEDED. THERE WAS NO REPORT OF PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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