BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3201788 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09528
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 5, 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

    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

    (B)(4). 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING ON (B)(6) 2013, HIS BLOOD GLUCOSE (BG) READING WAS IN THE RANGE OF 335 MG/DL TO 542 MG/DL. THE PATIENT REPORTEDLY HAD SYMPTOMS OF NAUSEA AND THIRST. THE PATIENT REPORTEDLY TREATED VIA BOLUSING FROM THE PUMP AND THEN TREATED VIA A 15 UNIT CORRECTION INJECTION OF HUMALOG AFTER HIS BGS CONTINUED TO ELEVATE. THE PATIENT¿S BG REPORTEDLY WENT DOWN TO 55 MG/DL AFTER TREATMENT. IT WAS NOTED THERE WAS AIR IN THE SYSTEM; THE PUMP REPORTEDLY EMITTED MULTIPLE NO PRIME/OCCLUSION WARNINGS AFTER THE SITE/SET AND CARTRIDGE WERE CHANGED AND PATIENT DID NOT HEAR ALARMS DUE TO A NOISY ENVIRONMENT. SUBSEQUENTLY IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE ANY INSULIN DELIVERY FOR 34 MINUTES. THE CARTRIDGE CAP WAS REPORTEDLY ON TIGHT, NO VISIBLE CRACKS WERE NOTED, THERE WAS NO CHANGE IN FORCE OR TEMPERATURE AND THE PUMP WAS NOT REBOOTING. THE PATIENT REPORTEDLY PRE-FILLED CARTRIDGES AHEAD OF TIME, CHANGED THE CARTRIDGE EVERY 1 ½ DAYS AND AT TIMES STORED CARTRIDGES WITH INSULIN IN A CLOSET. THE PATIENT DENIED RE-USING SUPPLIES. IT WAS NOTED THAT THE PATIENT INITIALLY CONTACTED ANIMAS STATING THE PUMP STOPPED DELIVERING INSULIN AFTER A ¿LOW CARTRIDGE¿ WARNING. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP AND NOTED THAT THE PUMP DID ALARM A ¿LOW CARTRIDGE¿ ALARM ON (B)(6) 2013 AT 9:12 AM AND HAD CONTINUED TO DELIVERING INSULIN UNTIL 9:17 AM, THE PUMP THEN EMITTED A NO PRIME WARNING AND THE PATIENT DID NOT COMPLETE THE PRIME STEPS UNTIL 9:56 AM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT WAS NOT RESPONDING TO ALARMS APPROPRIATELY, WAS WITHOUT INSULIN FOR A PERIOD OF TIME, THE INCORRECT STORAGE CONDITIONS WERE BEING USED FOR STORING INSULIN AND THE INCORRECT TECHNIQUE WAS USED FOR PRESSURING VIALS CAUSING AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301888 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening