BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2000574 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00562
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGES WERE RETURNED TO ANIMAS AND WERE INVESTIGATED BY PRODUCT ANALYSIS. THE RETURNED CARTRIDGE PASSED VISUAL INSPECTION AND THERE WAS NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH AIR BUBBLES BEING OBSERVED FROM THE INTERNAL O-RING AND EXITING FROM THE CENTER OF THE PLUNGER. THE PLUNGER WAS REMOVED AND DAMAGED O-RINGS WERE OBSERVED; O-RINGS APPEARED TO HAVE DIVOTS OR GROOVE NEAR THE O-RING MOLDING LINES. A TOTAL OF 2 USED CARTRIDGES WERE RETURNED; 1 FAILED LEAK TEST. A TOTAL OF 6 UNOPENED/UNUSED CARTRIDGES WERE RETURNED; 4 FAILED LEAK TEST, 2 PASSED LEAK TEST. IN CONCLUSION, THE INSULIN LEAKING ISSUE WAS CONFIRMED BY PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING AN ISSUE WITH INSULIN LEAKING WITH 3 INSULIN CARTRIDGES FROM THE SAME BOX. HE ALSO CLAIMED THAT HIS BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED IN THE 400S MG/DL; HOWEVER, HE DID NOT HAVE ANY SYMPTOMS AND HE DID NOT RECEIVE ANY MEDICAL INTERVENTION FROM ANOTHER PERSON. THE PATIENT SELF-TREATED WITH AN INSULIN INJECTION. THE ANIMAS REPRESENTATIVE WALKED THE PATIENT THROUGH TROUBLESHOOTING. THE PATIENT CONFIRMED THAT THERE WAS INSULIN LEAKING FROM THE PLUNGER SIDE OF THE CARTRIDGE. THE PATIENT WAS UNABLE TO IDENTIFY ANY STRUCTURAL DAMAGE TO THE CARTRIDGE. THE CARTRIDGES WERE REPLACED. AN ANIMAS REPRESENTATIVE FOLLOWED UP WITH THE PATIENT ON (B)(6) 2011. THE PATIENT INDICATED THAT HIS BLOOD GLUCOSE LEVELS RESUMED TO HIS USUAL RANGE AFTER USING THE NEW REPLACEMENT CARTRIDGES. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT SINCE THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION FROM ANOTHER PERSON; HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE INSULIN LEAKING ISSUE WITH HIS CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1