BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2359726 · Received December 6, 2011

    Report

    Report Number
    2531779-2011-09064
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    November 11, 2011
    Report Date
    November 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED FOR INVESTIGATION. A RETAIN SAMPLE FROM LOT # B201668 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST AND A FILL TEST WERE 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 PATIENT REPORTED THAT THE CARTRIDGE WAS DISCARDED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS EXPERIENCING ELEVATED BLOOD GLUCOSE OF 20 TO 22 MMOL/L. DURING TROUBLESHOOTING THE PATIENT NOTICED AN AIR BUBBLE IN THE CARTRIDGE. WHEN SHE ATTEMPTED TO PURGE THE BUBBLE FROM THE CARTRIDGE, SHE ACCIDENTLY PUSHED ALL OF THE INSULIN OUT OF THE CARTRIDGE. DURING A FOLLOW-UP CONTACT, THE PATIENT REPORTED THAT SHE WAS NOT SURE OF THE CAUSE OF THE AIR BUBBLES BUT SHE HAS CONTINUED TO USE THE PUMP WITHOUT FURTHER ISSUES WITH AIR BUBBLES AND HER BLOOD GLUCOSE HAS REMAINED IN HER TARGET RANGE.

    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 19 YR Required Intervention