BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050473 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02265
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON HAS REQUIRED MULTIPLE PRESSES TO OBTAIN A RESPONSE FOR THE PAST 2 TO 4 WEEKS. HE NOTED THAT THE BUTTON DOES NOT CLICK OR SPRING BACK WHEN PRESSED. THE PATIENT STATED THAT THE DOWN ARROW AND OK KEYPAD BUTTONS ARE RESPONDING AS EXPECTED. HE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT HE WEARS THE PUMP IN A CASE CLIPPED TO HIS WAIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR