BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070096 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02903
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND OVER THE PAST 2 MONTHS, AND NOW REQUIRE EXCESSIVE FORCE TO OBTAIN A RESPONSE. SHE NOTED THAT THE BUTTONS STILL CLICK, BUT DO NOT SPRING BACK WHEN PRESSED. THE PATIENT DENIED PHYSICAL DAMAGE TO THE KEYPAD; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP IN VARIOUS PLACES WITH A CASE OR A CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR