BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2772080 · Received October 4, 2012

    Report

    Report Number
    2531779-2012-11823
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 7, 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. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 DATE OF SUBMISSION (B)(4) 2012 - ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS OBTAINED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE VIBRATION MOTOR PINS WERE FOUND TO BE MISALIGNED. THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE AUDIBLE ALARM MECHANISMS STILL FUNCTION AND WILL STILL ALERT THE USER SHOULD THE PUMP EMIT AN ALARM.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/30/2012 - 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 FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE UP ARROW, DOWN ARROW AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE; THE CONTRAST BUTTON RESPONDED APPROPRIATELY. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS; NONE OF THE CONTACT BUTTONS HAD NORMAL TACTILE FEEL.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, THE KEYPAD BUTTON(S) IS NOT RESPONDING TO USER INPUT. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PUMP IS BEING RETURNED FOR INVESTIGATION. 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