BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2068039 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02542
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: NO PRODUCT WAS RETURNED; RETAINED SAMPLES WERE EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: TWO RETAIN SAMPLES WERE TESTED PER COMPLAINT - LOT# B201593 & B201595. THE CARTRIDGES PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. TWO RETAINS WERE PULLED, BOTH PASSED LEAK TESTING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE PRODUCT IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. IN ADDITION, A LOT # WAS NOT PROVIDED AND THEREFORE, NO INVESTIGATION RELATED TO RETAIN TESTING COULD BE COMPLETED AT THIS TIME. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ON (B)(6) 2011, ALLEGING THAT ON 2 OR 3 SEPARATE OCCASIONS IN (B)(6) 2010, HE SMELLED INSULIN FROM INSIDE THE PUMP. DURING THAT PERIOD, THE PT CLAIMED HE OBTAINED ELEVATED BLOOD GLUCOSE (BG) READINGS IN THE 200'S MG/DL AND TOOK EXTRA BOLUS CORRECTIONS WITH PUMP TO GET HIS BG DOWN. THE PT DENIED DEVELOPED SYMPTOMS OF NAUSEA, VOMITING, AND SHORTNESS OF BREATH. THE PT STATED HE DID NOT CHECK FOR KETONES. AT THE TIME OF TROUBLESHOOTING, THE PT CLAIMED HE NO LONGER HAD THE CARTRIDGES HE WAS USING DURING (B)(6) AND THEREFORE, WAS UNABLE TO PROVIDE THE CARTRIDGE LOT NUMBER. THE PT'S SUPPLIER WAS CONTACTED, HOWEVER, THEY WERE UNABLE TO CONFIRM WHICH CARTRIDGE LOT #'S WERE SHIPPED TO THE PT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PT DID NOT REPORT ANY BG READINGS OR SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION 1200/1250/2020/OTP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1