BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2030718 · Received March 22, 2011

    Report

    Report Number
    2531779-2011-01795
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED UNEXPLAINED BLOOD GLUCOSE LEVELS BETWEEN 200MG/DL AND 350MG/DL FOR TWO WEEKS; SHE DENIED SYMPTOMS OF HYPERGLYCEMIA AND DID NOT CHECK FOR KETONES. THE PT ATTRIBUTED THE BLOOD GLUCOSE EXCURSION TO THE CARTRIDGE LOT NUMBER THAT WAS DESCRIBED IN A NOTIFICATION REC'D FROM ANIMAS. AT THE TIME OF THE CONTACT, THE PT SAID HER BLOOD GLUCOSE WAS 197MG/DL. SHE STATED THAT SHE CHANGES THE CARTRIDGE AND INFUSION SET EVERY THREE DAYS, ROTATES LOCATIONS ON HER ABDOMEN USING NEW AND NON-SCARRED AREAS, DOES NOT RECALL SEEING ANY LEAKAGE OR AIR BUBBLES, AND HAS USED CARTRIDGES FROM THE SAME LOT NUMBER FOR THE PAST MONTH. SHE REVIEWED THE PUMP AND CONFIRMED THAT ALL PUMP SETTINGS WERE CORRECT, THE BASAL AND BOLUS DELIVERY HISTORY WAS ACCURATE, AND NO ASSOCIATED ALARMS WERE FOUND IN THE PUMP HISTORY. THE PT STATED THAT SHE USES RAPID-ACTING INSULIN, USED TWO DIFFERENT VIALS IN THE PAST TWO WEEKS, AND THE INSULIN WAS CLEAR, WITHIN EXPIRATION DATE, OPENED FOR LESS THAN 28 DAYS, AND STORED AT APPROPRIATE TEMPERATURES. SHE DENIED CHANGES IN PHYSICAL ACTIVITY, SIGNS OF ILLNESS, OR CHANGES IN MEDICATIONS. THE PT REPORTED THAT HER BLOOD GLUCOSE METER WAS WORKING CORRECTLY AS HER METER CORRESPONDS WITH THE READINGS IN THE PHYSICIAN'S OFFICE. SHE NOTED THAT HER HEMOGLOBIN A1C INCREASED RECENTLY TO 8.1% FROM 7.2% IN (B)(6) 2010. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE DEFECTIVE CARTRIDGES WITH LOT NUMBER B201581; THE BLOOD GLUCOSE ELEVATION DOES NOT MEET THE CRITERIA FOR AN ADVERSE EVENT.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR