BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3895700 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18323
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CORRECT CARTRIDGE LOT # IS D200072.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/11/2014-DEVICE EVALUATION: THE RETAINED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE RETAINED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CALLED AND ALLEGED THE PATIENT IS HOSPITALIZED WITH A BLOOD GLUCOSE OF 390 MG/DL, POLYDIPSIA AND SYMPTOMS OF DEHYDRATION. THE PATIENT IS A BRITTLE DIABETIC WITH FIBROMYALGIA, HYPERTENSION, AND HYPOTHYROIDISM, TAKING LYRICA, COZAAR, AND SYNTHROID. DURING TROUBLESHOOTING WITH CUSTOMER SUPPORT (CS), THE PATIENT STATED THERE WERE AIR BUBBLES IN THE CARTRIDGE. CS DETERMINED THAT THE PATIENT WAS NOT FILLING THE CARTRIDGE PER THE INSTRUCTIONS FOR USE, AND ATTRIBUTED THE BG EXCURSION TO TRAINING/MISUSE ISSUE. THE PATIENT HAS BEEN ON THE PUMP LESS THAN ONE MONTH AND ALLEGED HAVING RECEIVED INSUFFICIENT TRAINING IN PUMP USE AND FILLING THE CARTRIDGE. CS FOUND NO INDICATION OF PRODUCT MALFUNCTION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO THE USE ERROR OF IMPROPERLY FILLING THE CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371269 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR