BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2212371 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05907
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE KEYPAD SYMBOLS WERE FOUND TO BE WORN. DURING THE EVALUATION, THE OK AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE AND REQUIRED EXCESSIVE FORCE IN ORDER TO ELICIT A RESPONSE. ALL OF THE OTHER KEYPAD BUTTONS RESPONDED TO BUTTON PRESSES AS EXPECTED AND WERE FOUND TO SPRING BACK AND CLICK BACK NORMALLY. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE CONTRAST KEY CONTACTS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE KEYPAD BUTTONS REQUIRED MULTIPLE PRESSES TO RESPOND. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND CLEANED THE PUMP WITH AN ALCOHOL SWAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR