BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4033668 · Received August 25, 2014

    Report

    Report Number
    2531779-2014-24270
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    August 11, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE BATTERY CAP WAS NOT RETURNED AND A TEST CAP WAS USED IN THE EVALUATION. THE PUMP POWERED UP TO A DIM AND DISCOLORED DISPLAY WITH AUDIBLE AND VIBRATORY FEATURES. THE BATTERY COMPARTMENT WAS CRACKED AT THE THREADS AND EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE COMPARTMENT. A LEAK TEST SHOWED A LEAK WHERE THE CRACK WAS LOCATED. PUMP CASING WAS OPENED AND NO EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE THE PUMP. UNRELATED TO THE DISPLAY AND CASING ISSUE, THE BOLUS BUTTON COVER AND THE GRIP PAD WERE DAMAGED/PEELING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED, MOISTURE INTRUSION WAS EVIDENT IN THE COMPARTMENT, AND THE DISPLAY WAS DIM/DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514379 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1