BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2896799 · Received January 4, 2013

    Report

    Report Number
    2531779-2013-00173
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201840 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FORCE TEST, A FILL TEST, AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. 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 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 REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: HER DAUGHTER'S BLOOD GLUCOSE (BG) HAS BEEN RANGING FROM 300- 500MG/DL AND SHE HAS BEEN TIRED AND EXPERIENCING NAUSEA. MOM STATES WHEN BG IS HIGH SHE NORMALLY CORRECTS THROUGH THE PUMP AND IS ABLE TO BRING BG UNDER CONTROL. MOM STATES SHE NOTICED DURING CARTRIDGE CHANGES THAT THE CARTRIDGE COMPARTMENT SMELLS OF INSULIN AND INSULIN LEAKS FROM THE TOP OF THE CARTRIDGE WHERE THE LUER LOCK IS. MOM STATES A LOT OF TIMES THE LUER LOCK IS SOMEWHAT DIFFICULT TO SECURE. MOM STATES TIGHTENS ON THE TUBING AS TIGHT AS THE CARTRIDGE WILL ALLOW BUT THE TUBING IS STILL LOOSE. MOM DENIES ANY DAMAGE TO CARTRIDGE OR LUER LOCK. MOM ALSO DENIES ANY DAMAGE TO LUER LOCK OF THE INFUSION SET. MOM IS USING CARTRIDGES PER INSTRUCTIONS FOR USE AND CHANGING CARTRIDGES EVERY 2-3 DAYS. MOM DOES HAVE ANOTHER BOX OF CARTRIDGES WITH A DIFFERENT LOT. CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED MOM TO CHANGE CARTRIDGE TO ONE FROM A DIFFERENT LOT, TO CONTINUE TO MONITOR BG, AND TO EXAMINE NEW CARTRIDGES FOR ANY LEAKS. THE PATIENT IS CONTINUING ON THE PUMP WITH A CARTRIDGE FROM A NEW LOT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA RELATED TO A LEAKING CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4385 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening