BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2932754 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01270
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 6, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/03/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ISSUES. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT WAS FOUND TO BE MISALIGNED ON THE PRINTED CIRCUIT BOARD. UNRELATED TO THE ABOVE ISSUE, MULTIPLE REPLACE BATTERY ALARMS WERE OBSERVED IN THE PUMP BLACK BOX HISTORY; WHEN THE PUMP WAS OPENED A COLD SOLDER CONNECTION WAS FOUND. THE ISSUE IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT BECAUSE THE PUMP WAS ALARMING TO ALERT THE USER OF AN ISSUE. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. INVESTIGATION REVEALED THAT A FORCE SENSOR CIRCUIT COMPONENT WAS MISALIGNED. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39868 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1