BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5530231 · Received March 28, 2016

    Report

    Report Number
    2531779-2016-06711
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Report Date
    March 19, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 05/03/2016 DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RETAINED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER D200254 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 RELATED TO LOSS OF PRIME. 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, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE OVER 250 MG/DL BUT LESS THAN 500 MG/DL WITHOUT SYMPTOMS. THE PATIENT¿S BLOOD GLUCOSE READINGS DO NOT MEET ANIMAS¿ CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186387 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR