BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2931299 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01224
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) /2013 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201914 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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

    THE CARTRIDGE 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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE FOUND HER CARTRIDGE AND TUBING DISCONNECTED AT THE LUER LOCK. SHE STATED THAT THIS HAPPENS MOST OF THE TIME WHEN SHE IS ASLEEP. SHE ALSO STATED THAT THERE WERE BUBBLES AT ONE POINT. THE PATIENT STATED THAT THEIR BLOOD GLUCOSE (BG) WAS 587MG/DL WITH UPPER BODY ACHES, DRY MOUTH, NAUSEA AND KETONES. THE PATIENT STATED THAT THEY ARE SICK, THEY HAVE STREP THROAT AND ON AMOXICILLIN ANTIBIOTICS. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE AIR BUBBLES ISSUE WHICH COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE PATIENT'S BLOOD GLUCOSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36914 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening