BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2041743 · Received March 29, 2011

    Report

    Report Number
    2531779-2011-02009
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    December 3, 2010
    Report Date
    February 25, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201576 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH BLOOD GLUCOSE (BG) 344 MG/DL ACCOMPANIED BY EXTREME NAUSEA, EMESIS, ABDOMINAL CRAMPS, AND SYMPTOMS OF DEHYDRATION. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. A FAMILY MEMBER REPORTED THAT THE PATIENT'S BG READING WAS HI ON THE HOME BLOOD GLUCOSE METER AND SHE TREATED HER WITH CORRECTION INSULIN DOSE VIA SYRINGE PRIOR TO HOSPITALIZATION. SHE NOTED THAT SHE HAD CHANGED THE INFUSION SET TWICE WITHOUT IMPROVEMENT OF BG. THE FAMILY MEMBER REPORTED THAT UPON ADMISSION THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN AND ZOFRAN (ANTI-EMETIC). THE FAMILY MEMBER STATED THAT AT THE HOSPITAL THE INFUSION SET WAS REMOVED AND THE CANNULA WAS NOT BENT OR KINKED; WHEN THE CARTRIDGE WAS REMOVED A POOL OF INSULIN IN THE CARTRIDGE COMPARTMENT WAS OBSERVED. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT AND WAS DISCHARGED ON INSULIN PUMP THERAPY THE NEXT DAY WITH BG ABOUT 200 MG/DL. THE FAMILY MEMBER NOTED THAT SHE BELIEVED THAT THE PUMP SETTINGS WERE CORRECT. SHE STATED THAT OTHER CAUSES FOR THE BG EXCURSIONS WERE AS FOLLOWS: THE PATIENT WAS EXPERIENCING A GROWTH SPURT AND PUBERTY AND THE PHYSICIAN WAS STILL MAKING PUMP SETTING ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization