BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2887254 · Received December 27, 2012

    Report

    Report Number
    2531779-2012-15082
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013 - NO PRODUCT WAS RETURNED FOR DISPOSITION. A RETAINED CARTRIDGE SAMPLE FROM LOT # B201837 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE UP TO 25MMOL/L RELATED TO AIR BUBBLES IN THE CARTRIDGE. THE REPORTER STATED THAT WHEN THE BLOOD GLUCOSE WAS ELEVATED THE PATIENT HAD SYMPTOMS OF EXTREME NAUSEA, EXTREME HEADACHE, AND FEELING FLUSHED. THE REPORTER STATED THAT THE AIR BUBBLES HAD BEEN AN ISSUE FOR 2 TO 3 MONTHS. CUSTOMER SUPPORT WALKED THE REPORTER THROUGH THE PROPER CARTRIDGE FILLING TECHNIQUE. THE REPORTER INDICATED THAT THE CARTRIDGE WAS BEING OVER-CYCLED DURING THE FILLING PROCESS AND WAS ADVISED ON CYCLING THE CARTRIDGE 2-3 TIMES. THE REPORTER STATED THAT THEY WOULD GIVE THAT A TRY AND REPORT BACK WITH ANY FURTHER ISSUES. THERE HAVE BEEN NO FURTHER REPORTED ISSUES AT THIS TIME. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO A CARTRIDGE FILLING TECHNIQUE ISSUE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening