BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3201256 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09497
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUBJECT CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RESERVED SAMPLE FROM THE SAME LOT NUMBER, B201986, WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN REQUESTED FOR RETURN. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT HIS BLOOD GLUCOSE (BG) ELEVATED TO 542MG/DL WITH NAUSEA AND THIRST. TROUBLESHOOTING INDICATE THAT THE PUMP EMITTED A NO PRIME WARNING SHORTLY AFTER THE PATIENT HAD DELIVERED A BOLUS, AND THE PATIENT DIDN¿T PRIME THE PUMP UNTIL 34 MINUTES LATER. THE PATIENT¿S BG WAS REPORTEDLY ORIGINALLY 335MG/DL PRIOR TO THE BOLUS, BUT ELEVATED TO 542MG/DL AFTER THE PATIENT WAS WITHOUT INSULIN DUE TO THE UNCONFIRMED ALARM. TROUBLESHOOTING ALSO INDICATED THAT THE PATIENT PREFILLED CARTRIDGES WITH COLD INSULIN AND WAS NOT PRESSURIZING THE INSULIN VIAL CORRECTLY, RESULTING IN AIR BUBBLES IN THE SYSTEM. THE PATIENT DID NOTE AIR SPACES IN THE TUBING WHEN HE CHANGED THE SITE/SET IN RESPONSE TO ELEVATED BG. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THAT THE ELEVATED BG WAS CAUSED BY BEING WITHOUT INSULIN FOR 34 MINUTES AS WELL AS AIR IN THE TUBING. CTS ADVISED THE PATIENT ON PROPER FILL TECHNIQUE AND ON PRESSURIZING THE VIAL. THERE WAS NO CARTRIDGE DEFECT FOUND ON INVESTIGATION. ANIMAS DOES NOT MANUFACTURE THE INFUSION SET BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR OF THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301748 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening