BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4689866 · Received April 14, 2015

    Report

    Report Number
    2531779-2015-12487
    Event Type
    Injury
    Date Received
    April 14, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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

    DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME LOT NUMBER U200064 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. THE CARTRIDGE PASSED THE FORCE TEST. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. 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) 2015, THE REPORTER CONTACTED ANIMAS ALLEGING A MULTIPLE LOSS OF PRIME ISSUE WITH THE DEVICE. THE CARTRIDGE REPORTEDLY WAS BEING USED PER INSTRUCTIONS FOR USE (IFU). THE PATIENT REPORTEDLY EXPERIENCED A BLOOD GLUCOSE (BG) MEASUREMENT OF 32.5 MMOL/L WITH SYMPTOMS OF EXTREME THIRST, EXTREME DROWSINESS AND SHORTNESS OF BREATH. THE PATIENT REPORTEDLY DID NOT REQUIRE MEDICAL INTERVENTION. THE PATIENT REPORTEDLY REMAINED ON THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN ADVERSE EVENT AND TO DUE TO THE ALLEGED ISSUE NOT BEING RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248494 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening