BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2900234 · Received January 7, 2013

    Report

    Report Number
    2531779-2013-00302
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    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) 2012, THE HOSPITAL NURSE CALLED ANIMAS TO REQUEST THAT CUSTOMER TECHNICAL SUPPORT (CTS) FOLLOW-UP WITH A PATIENT WHO HAD BEEN ADMITTED FOR DIABETIC KETOACIDOSIS THROUGH THE EMERGENCY ROOM (ER) ON (B)(6) 2012 AFTER DISCONTINUING USE OF THE PUMP FOR 2-3 DAY FOR LACK OF SUPPLIES. THE PATIENT WAS A POOR HISTORIAN AND ALLEGEDLY HAD BEEN WITHOUT INSULIN FOR 2-3 DAYS PRIOR TO BEING ADMITTED. HER BLOOD GLUCOSE (BG) READ HI ON ADMISSION. PATIENT WAS NOT WEARING PUMP ON ADMISSION: STATES SHE HAD TAKEN THE PUMP OFF THE DAY BEFORE ON FRIDAY (B)(6) 2012 BECAUSE SHE DID NOT GIVE HER INSULIN FOR 2 DAYS PRIOT SINCE SHE DID NOT HAVE TEST STRIPS TO CHECK HER BG. SHE REPORTS HIGH BG FOR SEVERAL DAYS. ER TESTED FOR KETONE; SHE IS A POOR HISTORIAN AND COULD NOT RECALL WHAT LEVEL OF KETONES WERE PRESENT. SHE WAS REPORTEDLY NAUSEATED AND VOMITING, AND HAD HEADACHE DENIES ABDOMINAL PAIN, SHORTNESS OF BREATH OR CHEST PAIN. SHE WAS NOT ABLE TO GIVE CORRECTIONS BECAUSE SHE DID NOT HAVE TEST STRIPS TO CHECK HER BG LEVEL. DURING INVESTIGATION OF HIGH BG , CTS FOUND CARTRIDGE AND INSULIN WAS ONE WEEK OLD AND PATIENT HAS GONE TWO OR MORE WEEKS IN PAST WITHOUT CHANGING. INSULIN IS OK AND PATIENT DENIES SITE ISSUES, LUMPINESS OR HARDNESS, NO BLEEDING OR SCAR TISSUE. CHANGES SITE EVERY 7-14 DAYS. STATED ER TESTED FOR KETONES SHE IS A POOR HISTORIAN AND COULD NOT RECALL WHAT LEVEL OF KETONES WERE PRESENT. SHE DID NOT HAVE CARTRIDGE OR INFUSION SET WITH HER. CTS EXPLAINED IT IS RECOMMENDED TO CHANGE CARTRIDGE AND INFUSION SET EVERY 2-3 DAYS. ADVISED FOR HER TO CALL CTS BACK WHEN SHE RESUMES PUMP THERAPY TONIGHT IF SHE NEEDS ASSISTANCE OR IF SHE WOULD LIKE TO REVIEW ANY OF THE STEPS BEFORE SHE RESUMES THE PUMP. SHE VERBALIZED UNDER STANDING. THE PATIENT IS FILING CARTRIDGE CORRECTLY, REPORTS SHE FILLS CARTRIDGE TO 200 UNITS AND USES UNTIL IT RUNS TO 10 UNITS THIS COULD BE 1-2 WEEKS. STATES BG HAVE RUN OUT OF RANGE AND THEN IMPROVE FOR A LITTLE WHILE AFTER SHE CHANGES CARTRIDGE WITH NEW INSULIN. PT ALSO FILLING CANNULA WITH 1.0 UNITS OF INSULIN . PATIENT ALSO CHANGING INSET EVERY WEEK - TWO WEEKS. REVIEWED INSERTION TECHNIQUE AND FOUND IT TO BE ADEQUATE . CURRENT BG READING IS IN THE 120'S MG/DL. THE PATIENT WAS TO BE DISCHARGED TODAY, (B)(6) 2012. PATIENT REPORTS THE PUMP IS WORKING ADEQUATELY AND IT WAS NOT THE PUMP WHICH CONTRIBUTED TO THE ADMISSION. DENIES CHANGES IN MEDICATION, NO OTHER ILLNESS. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT IS KNOWINGLY USING CARTRIDGES AND INFUSION SETS LONGER THAN THE RECOMMENDED NUMBER OF DAYS . IT IS NOTED THAT USE ERROR MAY CONTRIBUTE TO THE EVENT, AS THE PATIENT DID NOT TESTING BG VALUES DUE TO LACK OF TESTING STRIPS, AND THEN ELECTIVELY REMOVED THE PUMP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7074 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization