BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3113277 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06432
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT CRACK OBSERVED IN THREAD AREA AND BELOW BUMPER PAD. NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THREADS INSIDE BATTERY COMPARTMENT ALSO DAMAGED. BATTERY CAP CAN NOT BE FULLY TIGHTENED DUE TO DAMAGED THREADS ON CAP, IN BATTERY COMPARTMENT AND BATTERY COMPARTMENT CRACK. A POWER LOSS WAS OBSERVED. A TEST CAP WAS USED AND WAS ALSO UNABLE TO FULLY TIGHTEN. VIBRATION MOTOR NOT RESPONDING. FOUND VIBRATION MOTOR ALIGNMENT PINS TO BE MISALIGNED. THE PUMP WAS NOT ABLE TO BE EXERCISED FOR 24 HOURS DUE TO A "NO CARTRIDGE DETECTED" WARNING DURING LOAD/STEP. PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE PUMP. FORCE SENSOR FLEX CABLE WAS FOUND TO BE CRACKED AT A BEND IN THE CABLE. CABLE EVENTUALLY BROKE WHEN THE CABLE WAS BEING STRAIGHTENED. 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.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A BATTERY COMPARTMENT CRACK, BATTERY COMPARTMENT THREADS DAMAGED, DAMAGED BATTERY CAP, FORCE SENSOR FLEX CABLE CRACKED, AND VIBRATION MOTOR UNALIGNED. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214436 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR