BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3863653 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16266
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 15, 2014
    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 AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS OBSERVED TO HAVE A CRACK IN THE BATTERY COMPARTMENT FROM THE FINGER PAD TO THE PRIMARY CASE SEAL. THERE WAS NO EVIDENCE OF MOISTURE INSIDE THE PUMP. THERE WERE NO ISSUES WITH POWER TO THE PUMP DURING TESTING. THE BOLUS BUTTON WAS FOUND TO BE DETACHED FROM THE PUMP AND THE INTERNAL BUTTON PLUG WAS MISSING. NO INTERNAL CONTAMINATION WAS OBSERVED INSIDE THE BUTTON. (B)(6).

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE BOLUS BUTTON INTERNAL PLUG WAS MISSING. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337586 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1