BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2603777 · Received June 7, 2012

    Report

    Report Number
    2531779-2012-05005
    Event Type
    Injury
    Date Received
    June 7, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/20/2012-DEVICE EVALUATION: A RETAIN CARTRIDGE SAMPLE FROM LOT # B201430 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE EXPIRATION DATE OF CARTRIDGE LOT# B201430 IS 2011/10; THE TEST RESULTS OF AN EXPIRED CARTRIDGE CANNOT BE DETERMINED PAST THE EXPIRATION DATE. THE CARTRIDGE PASSES VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER, O-RINGS, PLUNGER, OR CARTRIDGE BODY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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) 2012, THE REPORTER CONTACTED ANIMAS AND STATED THAT AROUND 5PM TO 6PM, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 325MG/DL WITH INCREASED THIRST AND BLURRED VISION. THE PATIENT WAS REPORTEDLY TREATED VIA CORRECTION INJECTION BASED ON THE PUMP'S CALCULATIONS. THE PATIENT'S BG REPORTEDLY WENT DOWN TO 58MG/DL 3 HOURS LATER AND THE REPORTER STATED THAT THE PATIENT FELT FINE. IT WAS NOTED THAT THE PATIENT'S BG WAS REPORTEDLY FLUCTUATING. THE PUMP REPORTEDLY EMITTED SEVERAL 'LOSS OF PRIME' WARNINGS. THERE WERE NOT SITE/SET OR CARTRIDGE ISSUES NOTED AND THE REPORTER STATED THAT THE PLUNGER WAS CYCLED 2 TO 3 TIMES A DAY. IT WAS INDICATED THAT THE REPORTER HAS BEEN USING EXPIRED CARTRIDGES. CUSTOMER SUPPORT (CS) ADVISED THE REPORTER NOT TO USE EXPIRED CARTRIDGES AS THE LUBRICATION CAN DRY OVER TIME WHICH CAN AFFECT THE MOVEMENT OF THE PLUNGER. THERE WERE NO PROGRAMMING OR SETTINGS ISSUES NOTED WITH THE PUMP. USE ERROR CONTRIBUTED TO THE REPORTED BG EXCURSION AS THE PATIENT WAS USING EXPIRED MATERIALS. THIS COMPLAINT IN BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201430

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening