BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2211099 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05866
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: NO DAMAGE WAS OBSERVED TO THE KEYPAD. THE KEYPAD WAS FOUND TO BE RESPONDING APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM; THIS HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE OK BUTTON WAS NOT RESPONDING APPROPRIATELY. THE FAMILY MEMBER REPORTED THAT THE OK BUTTON HAD TO BE PRESSED AT A SPECIFIC ANGLE IN ORDER TO ENGAGE. THE PATIENT REPORTEDLY WORE THE PUMP IN A "SPY BELT" AROUND HER WAIST 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 8 YR