BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2761302 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11324
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201824 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 PATIENT CLAIMED HER BLOOD GLUCOSE ELEVATED TO 519 MG/DL DUE TO RECEIVING MULTIPLE LOSS OF PRIME WARNINGS. THE PATIENT HAD SYMPTOMS OF FATIGUED AND THIRSTY BUT TESTED NEGATIVE FOR KETONES. ON THE AFTERNOON OF (B)(6), 2012, THE PATIENT BEGAN TO RECEIVE LOSS OF PRIME WARNING EVERY 10-30 MINUTES. HE REPORTEDLY HAD 5 LOSS OF PRIME WARNING THE FIRST DAY AND 7-8 MORE WARNING THE FOLLOWING DAY. BASED ON THE 519 MG/DL HE RECEIVED ON (B)(6) 2012 AT 9:30 PM, HE ADMINISTERED BOLUS INSULIN TO DECREASED HIS BLOOD GLUCOSE TO 236 MG/DL AND THEN TO 180 MG/DL AT 10:30 PM. THERE WAS NO PRODUCT MISUSE. THE ANIMAS REPRESENTATIVE RECOMMENDED THAT IF THE LOSS OF PRIME WARNING PERSISTS, REPLACED THE CARTRIDGE. THE PATIENT CHANGED THE CARTRIDGE USING ROOM TEMPERATURE INSULIN AS RECOMMENDED PER INSTRUCTION FOR USE. REPORTEDLY, SHE HAS NOT HAD ANY FURTHER LOSS OF PRIME ISSUE. THE PATIENT ADMITTED SHE WAS USING COLD INSULIN WHEN FILLING CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE OVER 500 MG/DL AFTER SHE EXPERIENCE MULTIPLE LOSS OF PRIME WARNINGS ON THE ANIMAS INSULIN PUMP.

    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 B201824

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R