BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2055599 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-02235
    Event Type
    Injury
    Date Received
    April 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP ON (B)(6) 2011 AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    LOT #: B201583, CORRECTION NUMBER:2531779-02/25/11-001-R. 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 # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. THE ORIGINAL MDR CONTAINED INFORMATION RELATING TO THE INSULIN INFUSION PUMP. THE COMPLAINT AS ORIGINALLY REPORTED BY THE CONSUMER TO ANIMAS WAS AGAINST THE CARTRIDGE, LOT # B201583. THIS CORRECTED REPORT CONTAINS THE APPROPRIATE INFORMATION AS IT RELATES TO THE CARTRIDGE.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT WAS USING CARTRIDGES FROM RECALLED LOT #B201583 DURING THE TIME THAT THE REPORTED BLOOD GLUCOSE EXCURSIONS OCCURRED. THE REPORTER STATED THAT SHE BELIEVED THE PATIENT'S BLOOD GLUCOSE EXCURSIONS WERE CAUSED BY THE LEAKING CARTRIDGE(S). SHE REFUSED TROUBLESHOOTING OF THE PUMP, AND STATED THAT SHE DID NOT BELIEVE THERE WERE ANY ISSUES WITH THE PUMP.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED THAT FOR FOUR MONTHS THE PT HAD OBTAINED ELEVATED BLOOD GLUCOSE READINGS RANGING UP TO 600 MG/DL. AT THAT TIME THE PT EXPERIENCED THE SYMPTOMS OF NAUSEA; HE WAS NEGATIVE FOR KETONES. ON AN UNSPECIFIED DATE, THE REPORTER NOTED A LEAKING CARTRIDGE. THE PT CORRECTED HIS ELEVATED BLOOD GLUCOSE LEVELS USING A BOLUS GIVEN VIA A SYRINGE. TROUBLESHOOTING REVEALED THERE WERE NO BENT OR KINKED CANNULAS, NO AIR BUBBLES IN THE CARTRIDGE, NO PROBLEMS WITH THE INFUSION SITE, AND ALL PUMP PROGRAMMING WAS CORRECT. THE BASAL/BOLUS TOTALS DELIVERED CORRECTLY MATCHED THOSE PROGRAMMED INTO THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R