BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2335432 · Received November 14, 2011

    Report

    Report Number
    2531779-2011-08516
    Event Type
    Injury
    Date Received
    November 14, 2011
    Report Date
    October 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 12/08/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS:THE RETURNED CARTRIDGE WAS OF LOT # B201276 WHICH EXPIRED IN (B)(6) 2009; THE PATIENT WAS USING A CARTRIDGE PAST ITS EXPIRATION DATE. THE RETURNED CARTRIDGE WAS OBSERVED TO HAVE TWO SMALL CRACKS AT THE TIP OF THE PLUNGER. DURING TESTING THE CARTRIDGE WAS FOUND TO BE LEAKING FROM THE CRACKS IN THE PLUNGER.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE CONTACTED ANIMAS TO REPORT A LEAKING CARTRIDGE. THE REPORTER CLAIMED THE PATIENT BEGAN EXPERIENCING HIGH BLOOD GLUCOSE READINGS IN THE 400-600 MG/DL RANGE ON THE EVENING OF (B)(6) 2011. THE PATIENT'S SPOUSE CONFIRMED THE PATIENT TESTED NEGATIVE FOR KETONES; HOWEVER, IT IS NOT KNOWN IF SHE DEVELOPED ANY SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. ON THE MORNING OF (B)(6) 2011, THE REPORTER STATED THE PATIENT'S BLOOD GLUCOSE WAS 499 MG/DL. IT WAS NOTED THAT THE PATIENT CHANGED THE SITE AND CARTRIDGE AND THIS IS WHEN SHE DISCOVERED INSULIN HAD LEAKED INTO THE CARTRIDGE COMPARTMENT. AT THE TIME OF TROUBLESHOOTING, THE REPORTER REPORTED A 1/8" CRACK WAS FOUND ON CARTRIDGE AT THE 1.0ML MARK. THE REPORTER DENIED ANY TRAUMA TO THE CARTRIDGE. ANIMAS CUSTOMER SUPPORT NOTED THE CARTRIDGE HAD AN EXPIRATION DATE OF DECEMBER 2009 AND INFORMED REPORTER AGAINST USE OF EXPIRED PRODUCT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED BLOOD GLUCOSE READINGS SUGGESTIVE OF HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201276

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR