BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2002656 · Received February 8, 2011

    Report

    Report Number
    2531779-2011-00705
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 9, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP OR CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE REPORTER INDICATED THAT THE PT'S CURRENT BG WAS "376 MG/DL" AND SHE HAD TRACE KETONES. THE PT REPORTEDLY CHANGED THE SET THE MORNING OF CONTACT BETWEEN THE REPORTER AND ANIMAS REP. THE PT WAS USING A NEW SITE (L HIP AREA). NO EVIDENT SCAR TISSUE WAS OBSERVED. THE SETS AND CARTRIDGES WERE BEING CHANGED EVERY 2 DAYS. THE REPORTER DENIED LEAKAGE, BLOOD, REDNESS, IRRITATION OR INFLAMMATION AT SKIN SITE. THE INFUSION SET WAS NOT INSERTED IN AREA OF FRICTION. THE PT WAS REPORTEDLY ROTATING SITES IN ROTATION PATTERN. THE REPORTER DENIED EVIDENCE OF A BENT OR KINKED CANNULA. THE LUER LOCK AND CARTRIDGE CAP WERE SECURE. NO AIR BUBBLES, BLOOD, OR KINKS WERE OBSERVED IN THE TUBING. THE REPORTER CONFIRMED THAT AN 8 UNIT AIR BOLUS WAS DELIVERED WITHOUT EVIDENCE OF AIR OR LEAKAGE. SHE ALSO DENIED LEAKAGE BUT CONFIRMED AIR BUBBLES IN CART. THE CARTRIDGE WAS AT ROOM TEMP. THE PT WAS CORRECTLY INSERTING THE FILLING NEEDLE INTO VIAL AND WAS DISCHARGING AIR TO PRESSURIZE. THE PT WAS FILLING THE CARTRIDGES. THE INSULIN WAS OK. THE REPORTER DENIED THAT THE PT WAS REUSING CARTRIDGES OR TUBING. THE TDD WAS ACCURATE. THE REPORTER DENIED MISSED BOLUSES IN HISTORY. SHE CONFIRMED THAT THE I:C RATIO, ISF, BG TARGETS, AND IOB SETTINGS WERE CORRECTLY PROGRAMMED. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE REPORTER'S CLAIM THAT THE CARTRIDGE HAD AIR BUBBLES. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PT'S REPORTED SYMPTOM AND BG READING DO NOT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201554

    Patients

    Seq Age Sex Outcome Treatment
    1