BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3190243 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09007
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DATE OF SUBMISSION 08/02/2013 DEVICE EVALUATION: A RETAIN CARTRIDGE WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED; A RETAIN SAMPLE FROM THE SAME LOT WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A LEAK, FORCE AND FILL TEST WAS PERFORMED WITH NO FAILURES. 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)(6) 2013, THE PATIENT¿S DOCTOR CONTACTED ANIMAS AND REPORTED IN THE MIDDLE OF THE NIGHT ON (B)(6) 2013, THE TUBING HAD DISCONNECTED FROM THE CARTRIDGE WITH THE CARTRIDGE CAP STILL SECURED TO THE PUMP. IT WAS NOTED WHEN THE PATIENT WENT TO BED ON (B)(6) 2013, HER BLOOD GLUCOSE (BG) MEASUREMENT READING WAS 7.2MMOL/L AND WHEN SHE AWOKE ON THE MORNING OF (B)(6) 2013, HER BG MEASUREMENT REPORTEDLY READ ¿HI¿ ON THE METER. THE PATIENT REPORTEDLY HAD KETONES, WAS VOMITING AND HAD ABDOMINAL PAIN. IT WAS NOTED THAT THE PATIENT WAS TREATED VIA CORRECTION INJECTION AND HER BG LEVELS RETURNED TO NORMAL RANGE. THERE WAS REPORTEDLY NO MEDICAL ATTENTION REQUIRED. THE PATIENT STATED THE TUBING AND CARTRIDGE WERE 2 DAYS OLD PRIOR TO HER HAVING THE HIGH BG. THE PATIENT REPORTEDLY DID NOT INSPECT THE SUPPLIES AND HAD DISCARDED THEM. THE PATIENT DENIED ANY LEAKING OR THAT THERE WAS A SMELL OF INSULIN FROM THE CARTRIDGE COMPARTMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY DUE TO THE ALLEGATION THAT THE TUBING CAME LOOSE FROM THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291096 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening