BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2892737 · Received January 2, 2013

    Report

    Report Number
    2531779-2013-00036
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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: A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201927 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FORCE TEST, A FILL TEST, AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF 511 MG/DL WITH LARGE KETONES AFTER RECEIVING A LOSS OF PRIME WARNING. THE LOSS OF PRIME REPORTEDLY OCCURRED AFTER A CARTRIDGE/SITE/SET CHANGE. THE PATIENT WAS REPORTEDLY TREATED WITH A CORRECTION INJECTION AND HIS BG AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT WAS 193 MG/DL WITH SMALL KETONES AND NO SYMPTOMS. TROUBLESHOOTING INDICATED INCORRECT CARTRIDGE FILL TECHNIQUE AND USE OF REFRIGERATED INSULIN. CUSTOMER SUPPORT ADVISED THE REPORTER ON PROPER CARTRIDGE FILL TECHNIQUE AND TO USE ROOM TEMPERATURE INSULIN. FOLLOW UP WITH THE REPORTER INDICATED THE CARTRIDGE HAD BEEN CHANGED AND THERE HAD BEEN NO FURTHER LOSS OF PRIME WARNINGS. THERE IS CURRENTLY NO INDICATION OR ALLEGATION OF A PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY. USE ERROR WAS DETERMINED AS A CAUSE/CONTRIBUTOR TO THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening