BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2554722 · Received May 1, 2012

    Report

    Report Number
    2531779-2012-03663
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS FOR EVALUATION AS IT WAS PAST THE EXPIRY DATE. THE PATIENT WAS NOT FOLLOWING CARTRIDGE IFU THAT RECOMMENDS DISCARDING THE DEVICE PAST EXPIRY DATE. HOWEVER, NO CONCLUSIONS CAN BE MADE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/19/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201491 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. USE ERROR CONTRIBUTED TO THE REPORTED COMPLAINT AS THE PATIENT WAS USING EXPIRED MATERIALS. ADDITIONAL TESTING WAS UNABLE TO BE DETERMINED DUE TO MATERIALS BEING PASSED THE EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) GREATER THAN 500MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REPORTED THAT WHEN SHE DISCONNECTED TO CHANGE THE CARTRIDGE AND INFUSION SET, THE INSULIN LOOKED LIKE GEL. SHE STATED THAT SHE REPLACED THE SUPPLIES AND ATTEMPTED TO DELIVER A CORRECTION BOLUS; SHE RECEIVED AN OCCLUSION ALARM. THE PATIENT NOTED THAT SHE CORRECTED WITH INSULIN VIA SYRINGE AND BG RESOLVED TO 200MG/DL. SHE CONFIRMED THAT THE VIAL OF INSULIN IS NOT EXPIRED AND THE LIQUID IS CLEAR AND NON- VISCOUS. CUSTOMER SUPPORT REVIEWED THE PUMP AND SUPPLIES WITH THE PATIENT AND DISCOVERED THAT THE PATIENT WAS USING EXPIRED CARTRIDGES (EXPIRATION DATE = 2012-02). IT IS UNKNOWN IF THE EXPIRED CARTRIDGES CAUSED THE CHANGE IN INSULIN CONSISTENCY AND/OR IF THE CONSISTENCY WAS RESPONSIBLE FOR THE BG EXCURSION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT USED EXPIRED CARTRIDGES AND INSULIN THAT MAY NOT HAVE BEEN VIABLE AROUND THE SAME TIME AS THE HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening