BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3082663 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05499
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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)(6) 2013 DEVICE EVALUATION: A RESERVED CARTRIDGE SAMPLE FROM THE SAME LOT NUMBER WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS WERE NOTED. THE CARTRIDGE PASSED THE LEAK, FILL AND FORCE TEST. 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) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013, THE PATIENT AWOKE WITH BLOOD GLUCOSE (BG) OF 502MG/DL WITH HEADACHE, NAUSEA, ABDOMINAL PAIN, DIZZINESS, AND MODERATE TO LARGE KETONES. THE PATIENT'S BG WAS REPORTEDLY TREATED WITH WATER AND A SYRINGE INJECTION. THE REPORTER NOTED THAT THEY OVER-CORRECTED FOR THE HIGH BG AND THE PATIENT'S BG WENT TO 37MG/DL. THE LOW BG WAS REPORTEDLY TREATED WITH JUICE, AND THE PATIENT'S BGS REPORTEDLY RETURNED TO NORMAL RANGE. THE REPORTER STATED THAT THE INFUSION SET AND CARTRIDGE WERE CHANGED, AND A CARTRIDGE LEAK WAS NOTED AT THAT TIME. THE REPORTER STATED THE HUB END OF THE CARTRIDGE SEEMED TOO SHORT, ALTHOUGH THE INFUSION SET SEEMED TO ATTACH SECURELY. THE REPORTER STATED THAT THE PATIENT'S BG CAME DOWN AFTER THE SUPPLY CHANGE AND THAT BGS HAVE BEEN WITHIN NORMAL RANGE SINCE. THE REPORTED LOW BG HAS BEEN ATTRIBUTED TO DIABETES MANAGEMENT FACTORS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO A CARTRIDGE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185784 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B201833

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening