BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5138025 · Received October 8, 2015

    Report

    Report Number
    2531779-2015-36270
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 20, 2015
    Report Date
    September 21, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    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 #2 DATE OF SUBMISSION 12/14/2015-DEVICE EVALUATION: THE REPORTER STATED THAT THE ALLEGED ISSUE OCCURRED WITH EITHER CARTRIDGE LOT # D200169 OR WITH CARTRIDGE LOT # D200173. AS THE REPORTER WAS UNSURE WHICH LOT # THE ALLEGED ISSUE OCCURRED WITH, CARTRIDGES FROM BOTH LOT #S WERE RETURNED. ADDITIONAL RETURNED CARTRIDGES WERE EVALUATED BY PRODUCT ANALYSIS ON 11/20/2015 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGES WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 11/02/2015-DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: SIX UNOPENED CARTRIDGES AND ONE OPENED CARTRIDGE WERE RETURNED. A VISUAL INSPECTION OF THE CARTRIDGES WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A RETAIN CARTRIDGE SAMPLE FROM THE SAME LOT WAS ALSO TESTING WITH NO FAILURES FOUND. 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

    ON (B)(4) 2015, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2015 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) GREATER THAN 600MG/DL WITH CHEST PAIN, NECK AND SHOULDER PAIN, VOMITING, NAUSEA, EXTREME THIRST, EXCESS URINATION, AND LARGE KETONES. THE PATIENT WAS REPORTEDLY HOSPITALIZED AND TREATED WITH IV FLUIDS, INSULIN INJECTIONS, AND INSULIN VIA THE PUMP. THE REPORTER STATED THAT THE PATIENT FILLED A CARTRIDGE ON (B)(6) 2015, AND WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL THE FOLLOWING DAY THE HEALTHCARE PROVIDER REMOVED THE CARTRIDGE FROM THE PUMP AND FOUND THAT THERE WAS NO INSULIN IN THE CARTRIDGE. THERE WAS NO ALLEGATION OF POWER LOSS. THE PUMP REPORTEDLY WAS GIVING A REMAINING INSULIN READING OF 106 UNITS AT THE TIME THE CARTRIDGE WAS DISCOVERED TO BE EMPTY. THE ISSUE REPORTEDLY OCCURRED WITH ONE CARTRIDGE. THE PATIENT'S HEALTHCARE PROVIDER INSISTED THAT THE CARTRIDGE BE REPLACED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERED HYPERGLYCEMIA ASSOCIATED WITH A CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668677 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200173

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| L| R