BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2027687 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01586
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CLAIMED THAT THERE WAS A LEAKAGE IN HER INSULIN CARTRIDGE WHEN SHE REPLACED IT INTO THE INSULIN PUMP ON (B)(6) 2011. SUBSEQUENTLY FOR THE FOLLOWING TWO DAYS, THE PATIENT OBTAINED BLOOD GLUCOSE IN THE 200-300 MG/DL. SHE REPORTEDLY TESTED FOR LARGE KETONES ON THE DAY OF CONCERN. ACCORDING TO THE PATIENT HIS BLOOD GLUCOSE READINGS OF "211, 220, 212, 277, AND 220 MG/DL" THROUGHOUT THE NIGHT OF (B)(6) 2011 DID NOT RESPONDING TO THE INSULIN CORRECTION. ON THE (B)(6) 2011, THE PATIENT OBTAINED MEDICAL INTERVENTION WITH CORRECTION INSULIN IN THE FORM OF HOMOLOG PEN FROM HER HEALTHCARE PROVIDER. IN ADDITION, HER WATER INTAKE WAS INCREASED TO CLEAR HER KETONIC CONDITION. DURING TROUBLESHOOTING, THE PATIENT CLAIMED THAT 10 MINUTES PRIOR TO THE REPLACEMENT OF THE INSULIN CARTRIDGE, SHE DISCOVERED THE LEAKAGE ON THE PLUNGER END OF THE CARTRIDGE. THE PATIENT DID NOT DETECT ANY VISIBLE DAMAGE NEITHER ON THE CARTRIDGE, OR RINGS, NOR THE PLUNGER RING. HOWEVER, SHE NOTICED THAT THERE WERE BUBBLES AND MOISTURE IN THE PLASTIC OF THE PLUNGER. THE 8 REMAINING CARTRIDGES WILL BE RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS. THE PATIENT CLAIMED THAT SHE HAD LARGE AMOUNTS OF KETONES AND RECEIVED MEDICAL INTERVENTION ACCORDINGLY WHILE SHE USED THE ALLEGED LEAKING CARTRIDGE OF INSULIN WITH THE ANIMAS INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/ 2020/OTP B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R