BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2271065 · Received September 30, 2011

    Report

    Report Number
    2531779-2011-07248
    Event Type
    Injury
    Date Received
    September 30, 2011
    Report Date
    September 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SENT BACK 5 UNUSED CARTRIDGES TO ANIMAS WITH THE REPORTED LOT #. THE CARTRIDGES WERE EVALUATED AND PASSED VISUAL INSPECTION. NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A LEAK TESTED WAS PERFORMED ON ALL OF THE RETURNED CARTRIDGES AND NO LEAKS FROM ANY AREA OF THE CARTRIDGES WAS OBSERVED. LOT #B201683.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT SHE FOUND MOISTURE IN THE CARTRIDGE COMPARTMENT OF HER PUMP. THE PATIENT CLAIMED THAT FOR THE PREVIOUS 2 WEEKS, SHE NOTICED THAT THE OUTSIDE OF THE CARTRIDGE WOULD BE WET UPON REMOVAL FROM THE CARTRIDGE COMPARTMENT. DURING THAT TIME, THE PATIENT CLAIMED THAT HER BLOOD GLUCOSE (BG) LEVELS HAD BEEN RUNNING HIGH AND SHE HAD DEVELOPED SYMPTOMS OF TIREDNESS AND THIRST. THE PATIENT MENTIONED AT HER HIGHEST BG RESULT WAS "HI" (BG > 500 MG/DL). THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING INSULIN VIA SYRINGE. THE PATIENT'S REMAINING UNUSED CARTRIDGES WERE REPLACED. THE PATIENT'S CARTRIDGE CAP WAS REPORTEDLY SECURE. THE PATIENT DENIED THAT THE PUMP WAS EXPOSED TO MOISTURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE HAD LEAKING CARTRIDGES AND SHE DEVELOPED AN ELEVATED BG LEVEL WITH SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    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 36 YR Life Threatening