BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1894555 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02149
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT (NO PEELING/LIFTING) BUT THE PUMP WAS INTERMITTENTLY RESPONDING TO THE KEYPAD BUTTONS, THE UP KEY WAS MISALIGNED, ALL THE KEY CONTACTS WERE INVERTED AND DID NOT ALWAYS SPRING BACK, THE BOLUS BUTTON WAS HARD TO PUSH, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE DOWN ARROW BUTTON IS NOT ALWAYS RESPONDING TO BUTTON PRESSES AND THAT SHE WAS NOT ABLE TO GIVE THE CORRECT AMOUNT OF INSULIN AS A RESULT OF THE BUTTON ISSUE. SHE STATED SHE GAVE 0.25 UNITS OF INSULIN MORE THAN SHE NEEDED A COUPLE OF TIMES AND CLAIMED THAT SHE HAD A LOW BLOOD GLUCOSE EVENT ONE OF THE TIMES. THE PT WAS UNABLE TO PROVIDE DATES/TIMES AND WHAT HER BLOOD GLUCOSE RESULT WAS AT THE TIME BUT INDICATED THAT SHE SELF-TREATED WITH FOOD. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO WATER AND DOES NOT HAVE ANY VISIBLE DAMAGE TO THE BUTTONS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD A LOW BLOOD GLUCOSE EVENT AS A RESULT OF THE BUTTON ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R