BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4110796 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27150
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: A BATTERY COMPARTMENT CRACK WAS OBSERVED; MOISTURE WAS FOUND WITHIN THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE BATTERY CAP CONTACT DIMENSIONS WERE WITHIN SPECIFICATION. THE BATTERY CAP WAS ABLE TO BE SECURED PROPERLY. NO POWER ISSUES WERE EXPERIENCED. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE KEYPAD WAS FOUND TO BE INTACT AND WITHOUT DAMAGE. EVALUATION REVEALED THE UP, DOWN, AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE UP, DOWN, AND CONTRAST KEY CONTACTS. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THERE WAS NO EVIDENCE OF MOISTURE, DAMAGE, OR DEFECT TO THE PUMP¿S INTERNAL COMPONENTS. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND CONTAMINATION, BATTERY CAP CONTAMINATION, DIM AND DISCOLORED DISPLAY SCREEN, AND A KEYPAD RESPONSE AND CONTAMINATION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF THE INVESTIGATION PERFORMED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589942 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR