BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2862414 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14319
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THE FOLLOWING: THE CARTRIDGES (LOT # B201865 EXP DATE 05/2014 ) ARE DAMAGED PRIOR TO USE AND THE PATIENT IS UNABLE TO SECURE THE TUBING TO THE CARTRIDGE PROPERLY, CAUSING THE TUBING TO CONNECT ON CROOKEDLY. ALLEGEDLY DUE TO THE ISSUE THE PATIENT HAS HAD BLOOD GLUCOSE (BG)S AS HIGH AS THE 400'S MG/DL WITH SYMPTOMS OF KETONES IN URINE, AND FATIGUE, AND AS LOW AS 61 MG/DL (NO SYMPTOMS). THE PATIENT HAS CHANGED HIS SITE MULTIPLE TIMES AND NOTICED NO CHANGE IN THE BG. PARENT CHANGED THE CARTRIDGE 3-4 TIMES (PARENT IS A POOR HISTORIAN) AND WITH THE LAST CARTRIDGE CHANGE SHE HAS NOTICED THAT THE BG'S ARE IN NORMAL RANGE. THE REPORTER STATES THE CARTRIDGES ARE USED PER INSTRUCTIONS, AND THE PATIENT IS CONTINUING TO SES AIR BUBBLES 2-3 INCHES IN THE TUBING THE PUMP NOT AVAILABLE FOR REVIEW TO CONFIRM PATIENT DISCONNECTION. THE MOST RECENT BG WAS 114MG/DL. PATIENT HAS RESUMED USE OF THE PUMP AT THIS TIME USING A CARTRIDGE FROM A DIFFERENT BOX. CUSTOMER SUPPORT ADVISED THE PARENT NOT TO USED DEFECTIVE CARTRIDGES, TO MONITOR THE BG, AND CALL BACK WITH ANY OTHER ISSUES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT DEFECTIVE CARTRIDGES MAY HAVE LEAD TO DISRUPTION IN INSULIN DELIVERY AND HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS IR 1000 CARTRIDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening