BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1901575 · Received November 10, 2010

    Report

    Report Number
    2531779-2010-02211
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010/003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE DISPLAY SCREEN WAS MISALIGNED. THE FORCE SENSOR PINS WERE PARTIALLY DISLODGED. AN "EZPRIME" OPERATION WAS PERFORMED WITH NO LOSS OF PRIME WARNINGS DUPLICATED. THE PUMP WAS EXERCISED WITH NO LOSS OF PRIME WARNINGS DUPLICATED. THE PUMP WAS FOUND TO DELIVER INSULIN ACCURATELY. THE PUMP HISTORY REVEALED A LOSS OF PRIME ALARM AT 1:05 AM THE MORNING THE PT ALLEGEDLY EXPERIENCED THE 435 MG/DL BLOOD GLUCOSE ELEVATION AND FELT SLIGHTLY NAUSEOUS. THE PUMP WAS NOT REPRIMED UNTIL 7:39 AM THAT MORNING. THE ELEVATED BLOOD GLUCOSE LEVEL WAS SELF TREATED AND IS NOT INDICATIVE OF A SERIOUS DIABETIC INJURY AS THE PT'S NAUSEA WAS ALSO DESCRIBED AS "SLIGHT".

    Description of Event or Problem · 1

    THE PT REPORTEDLY WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 435 MG/DL AND SLIGHT NAUSEA. THE PT WAS ABLE TO SELF TREAT THE SYMPTOM WITH A BOLUS INSULIN DOSE. THE PT MENTIONED THAT THE PUMP HAS BEEN RANDOMLY LOSING PRIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR