BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER

    MDR report key: 2069630 · Received April 26, 2011

    Report

    Report Number
    2531779-2011-02861
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 27, 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

    (B)(4). DEVICE EVALUATION: TWO CARTRIDGE WERE RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE CARTRIDGES PASS INITIAL VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED ON BOTH CARTRIDGES, ONE CARTRIDGE PASSED LEAK TESTING. THE SECOND CARTRIDGE WAS FOUND TO BE LEAKING FROM THE PLUNGER SIDE OF THE CARTRIDGE PAST THE FIRST O-RING AND OUT THE HOLE IN BETWEEN THE TWO O-RINGS. NO FURTHER FAILURES WERE FOUND WITH ADDITIONAL RETAIN TESTING OF THE CARTRIDGE LOT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 05/10/2011 - DEVICE EVALUATION: EVALUATION WAS PERFORMED BY PRODUCT ANALYSIS ON 06/03/2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED; A RETAINED SAMPLE WAS TESTED. THE CARTRIDGE PASSES 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.

    Additional Manufacturer Narrative · 1

    (BRAND NAME): ANIMAS INSULIN CARTRIDGE. (LOT #): B201618. (EXPIRATION DATE): 10/31/2012. THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CONTACTED ANIMAS ALLEGING THAT LARGE DROPS OF INSULIN CAME OUT OF PUMP CARTRIDGE COMPARTMENT WHILE CHANGING OUT THE CARTRIDGE. THE PATIENT DENIED DEVELOPING SIGNS/SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT CLAIMED HIS BLOOD GLUCOSE (BG) WAS 212 MG/DL ON THE MORNING OF (B)(6) 2011 AND AT THE TIME OF THE CALL HIS BG WAS 189 MG/DL. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED THAT THE CARTRIDGE HAD BEEN IN THE PUMP FOR THREE DAYS. AT THE TIME OF THE CALL, THE PATIENT CLAIMED THE CARTRIDGE WAS EMPTY AND THEREFORE WAS UNABLE TO DETERMINE WHERE ON CARTRIDGE INSULIN WAS LEAKING FROM. THE PATIENT CONFIRMED THAT THE INSULIN IN THE PUMP'S CARTRIDGE COMPARTMENT WAS NOT FROM A PREVIOUS LEAKING CARTRIDGE THAT WAS CALLED IN TO ANIMAS IN (B)(4) 2011. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1