BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2313988 · Received October 28, 2011

    Report

    Report Number
    2531779-2011-08065
    Event Type
    Injury
    Date Received
    October 28, 2011
    Report Date
    October 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 DEVICE EVALUATION: A CARTRIDGE OF LOT NUMBER B201680 HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST AND A LEAK TEST WERE PERFORMED WITH NO FAILURES OBSERVED. 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

    THE PATIENT'S DAD/REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 340-380 MG/DL 3-4 TIMES PER WEEK FOR THE PAST 2 WEEKS DUE TO CHRONIC AIR BUBBLES ISSUES IN THE CARTRIDGE. THE REPORTER CLAIMED THE PATIENT HAD SYMPTOM OF FREQUENT URINATION BUT WAS NEGATIVE FOR KETONES AT THE TIME OF CONCERN. DESPITE HIS CORRECT TECHNIQUE TO REMOVE THE AIR BUBBLES FROM THE CARTRIDGE, THE ISSUE WAS NOT RESOLVED. THERE WAS NO INSULIN PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED INCIDENT; HOWEVER, THE ANIMAS PUMP AND CARTRIDGE WERE REPLACED AS REQUESTED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA DUE TO THE AIR BUBBLE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R