BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 6093180 · Received November 10, 2016

    Report

    Report Number
    2531779-2016-31160
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100167
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 12/09/2016. NO PRODUCT WAS RETURNED. A RETAINED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER U200129 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: A LOT REVIEW INVESTIGATION OF THE INCOMING CARTRIDGES PER LOT WAS COMPLETED PRIOR TO RELEASE OF THIS LOT AND ENSURED THAT ALL CARTRIDGES PASSED FOR THIS LOT. THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND. 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) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE USER HAD BLOOD GLUCOSE LEVELS OVER 250 MG/DL, BUT LESS THAN 500 MG/DL WITHOUT SYMPTOMS ASSOCIATED WITH A CARTRIDGE ISSUE. THE REPORTER STATED THAT THE USER CHANGED THEIR SITE AND SET. THE USER WAS INSTRUCTED TO CHANGE TO A DIFFERENT LOT NUMBER AND SEE IF THE PROBLEM RESOLVED. THE PATIENTS BLOOD GLUCOSE READINGS DO NOT MEET ANIMAS CRITERIA OF A SERIOUS INJURY. THIS IS POTENTIALLY REPORTABLE BECAUSE THE ISSUE IS NOT ALWAYS OBVIOUS AND DETECTABLE PRIOR TO USE AND CAN RESULT IN UNDER-DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744453 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION 10840406100167

    Patients

    Seq Age Sex Outcome Treatment
    1