BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042051 · Received March 24, 2011

    Report

    Report Number
    2531779-2011-01938
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT #B201582 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 REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT A LEAKING CARTRIDGE CONTRIBUTED TO THE PATIENT'S HIGH BLOOD GLUCOSE (BG) LEVEL AND HOSPITALIZATION. THE REPORTER INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR DKA DURING THE LAST WEEKEND OF (B)(6) AND WAS TREATED WITH IV INSULIN. SHE WAS UNABLE TO PROVIDE ANY SPECIFIC BG VALUES OBTAINED DURING THE TIME OF CONCERN. THE REPORTER CLAIMED THAT AT THE TIME, THE PATIENT'S SITE WAS FINE WITH NO KINKS OR LEAKING NOTED. THE REPORTER ALSO DENIED OBSERVING AIR BUBBLES OR MOISTURE ON THE CARTRIDGE OR CARTRIDGE COMPARTMENT. THE CARTRIDGE WAS REPORTEDLY DISCARDED AND THE REPORTER DID NOT HAVE THE PUMP WITH HER AT THE TIME OF THE CALL WITH ANIMAS FOR TROUBLESHOOTING. THE REPORTER CLAIMED THAT THERE WERE NO ALARMS AND THE PATIENT DID NOT HAVE ANY FURTHER BG ISSUES AFTER BEING RELEASED FROM THE HOSPITAL. THE REPORTER DID NOT IMPLICATE THE PUMP FOR THE PATIENT'S HOSPITALIZATION. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT A PATIENT WAS HOSPITALIZED AND TREATED WITH IV INSULIN BECAUSE OF A LEAKING CARTRIDGE ISSUE.

    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 B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| L| R