BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 6206355 · Received December 27, 2016

    Report

    Report Number
    2531779-2016-34778
    Event Type
    Injury
    Date Received
    December 27, 2016
    Report Date
    December 4, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100129
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/17/2017. DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. A RETAIN SAMPLE FROM THE SAME LOT NUMBER D200342 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND RELATED TO OCCLUSION ISSUE. 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. A LOT REVIEW WAS PERFORMED AND NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 504 MG/DL ASSOCIATED WITH AN OCCLUSION ALARM ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS DETERMINED THAT THE USER WAS NOT USING THE CARTRIDGE PER ITS INSTRUCTIONS FOR USE AND THERE WAS AN OVER/UNDER CYCLING OF THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA AS A RESULT OF USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856655 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200342 10840406100129

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening