BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2061214 · Received April 4, 2011

    Report

    Report Number
    2531779-2011-02100
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201575 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PATIENT OBTAINED HIGH BLOOD GLUCOSE (BG) READINGS IN THE 200 AND 300 MG/DL RANGE WHEN USING CARTRIDGE LOT B201575. THE REPORTER DENIED THAT THE PATIENT HAD SYMPTOMS OF NAUSEA, VOMITING OR SHORTNESS OF BREATH; HOWEVER , CLAIMED THAT A COUPLE OF TIMES THE PATIENT TESTED POSITIVE FOR KETONES. THE PATIENT'S MOTHER STATED THAT CORRECTIONS WERE DONE USING THE PUMP AND OTHER TIMES USING SYRINGE. THE REPORTER CONFIRMED THAT THE PATIENT'S BG HAS BEEN BETTER SINCE USING A CARTRIDGE OF A DIFFERENT LOT NUMBER. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER REPORTED THAT SHE SMELLED INSULIN WHEN CHANGING OUT PREVIOUS CARTRIDGES AND DID NOTICE AIR BUBBLES IN THE CARTRIDGE. AT THE TIME OF THE CALL, THE REPORTER CONFIRMED THAT SITE APPEARED IN GOOD CONDITION, THERE WAS NO MOISTURE IN PUMP, CONFIRMED DATE/TIME, BASAL, ADVANCED BOLUS SETTINGS WERE CORRECT, AND TDD ADDED UP PROPERLY. THE REPORTER STATED SHE WAS USING REFRIGERATED INSULIN.

    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 B201575

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R