BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2472642 · Received February 29, 2012

    Report

    Report Number
    2531779-2012-01643
    Event Type
    Injury
    Date Received
    February 29, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A RESERVED SAMPLE FROM THE SAME LOT NUMBER B201737 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. A FORCE TEST WAS PERFORMED WITH NO FAILURES NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES NOTED INSIDE 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. USE ERROR CAUSED OR CONTRIBUTED THE REPORTED BG EVENT AS THE REPORTER STATED USING REFRIGERATED INSULIN. NO CONCLUSIONS CAN BE MADE AT THIS TIME. .

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) IN THE RANGE OF 400-600MG/DL WITH NO SIGNS OR SYMPTOMS. THE REPORTER CLAIMED THAT SHE FOUND AIR BUBBLES IN THE LUER CONNECTION WITH EACH SET CHANGE AND STATED THAT AIR BUBBLES IN THE LUER LOCK HAVE BEEN ONGOING. SHE CLAIMED THAT SHE USES REFRIGERATED INSULIN AND INDICATED THAT SHE WAS NOT AWARE THAT COLD INSULIN NEEDED TO SIT OUT TO ROOM TEMPERATURE TO AVOID AIR BUBBLES. THE REPORTER STATED THAT SHE DISCONNECTS THE PATIENT FROM THE TUBING AND WILL USUALLY BLOW AIR INTO THE CONNECTOR PIECE AND TAPS ON THE CARTRIDGE TO HELP GET RID OF BUBBLES AND THEN RECONNECTS THE TUBING TO PRIME OUT THE AIR BUBBLES. SHE ALSO STATED THAT THE BUBBLES WOULD REOCCUR A FEW HOURS LATER. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) PROVIDED INSTRUCTIONS ON HOW TO REMOVE THE AIR BUBBLES FROM THE LUER CONNECTION AND THE REPORTER CONFIRMED THAT THE AIR BUBBLES WERE GONE. IT WAS NOTED AFTER THE PATIENT'S SITE/SET WAS CHANGED OUT AND WAS GIVEN A BOLUS VIA THE PUMP; THE PATIENT'S BG REPORTEDLY WENT BACK TO NORMAL RANGE. CS PROVIDED INSTRUCTIONS ON THE IMPORTANCE OF USING ROOM TEMPERATURE INSULIN AND PROVIDED INSTRUCTIONS ON THE PROPER TECHNIQUES TO USE IF AIR BUBBLES ARE FORMED. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY. USE ERROR CAUSED OR CONTRIBUTED TO THE REPORTED HIGH BG DUE TO THE USE OF COLD INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention