BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2483151 · Received March 8, 2012

    Report

    Report Number
    2531779-2012-01882
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Report Date
    February 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGES WERE REPORTED TO BE FROM LOT #B201608 WITH EXPIRATION DATE OF 10/30/2012. THE CARTRIDGES HAVE NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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)(4) 2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201608 WAS TESTED. A VISUAL INSPECTION, FILL TEST AND LEAK TEST WAS PERFORMED ON THE CARTRIDGE WITH NO DAMAGE OR DEFECTS 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) 2012, IT WAS REPORTED THAT THE CARTRIDGE COMPARTMENT WAS FILLED WITH INSULIN AT LEAST THREE TIMES IN THE PAST TWO TO THREE WEEKS. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) RANGED BETWEEN 60MG/DL AND 300MG/DL WITH NO REPORTED SYMPTOMS OR MEDICAL INTERVENTION. IT WAS NOTED THAT THE BG RESOLVED AFTER THE INFUSION SET WAS CHANGED. THE REPORTER CONFIRMED THAT THE CARTRIDGES WERE NOT SAVED FOR RETURN AND WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAILS OF THE EVENTS. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE IMPLIED ALLEGATION THAT MULTIPLE CARTRIDGES LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR