BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2071181 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02937
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INVESTIGATION NECESSARY. THE RETAIN CARTRIDGE LOT# B201581 WAS CONFIRMED TO BE DEFECTIVE AND 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-RNGS. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT REQUESTED BACK AS THE ISSUE INVOLVED A RECALL LOT #. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT HE HAD "HIGH BLOOD GLUCOSE" WHILE USING THE ALLEGED RECALL CARTRIDGE NUMBER B201581 DURING SEPTEMBER 2010 AND DECEMBER 2010. SINCE, THE CARTRIDGE HAS BEEN REPLACED, THE PATIENT'S BLOOD GLUCOSE "IS GOOD NOW". THE PATIENT WENT TO ER WHEN THE PATIENT'S BLOOD GLUCOSE WAS HIGH. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SYMPTOMS THAT WOULD SUGGEST HYPOGLYCEMIA OR HYPERGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR "HIGH BLOOD GLUCOSE" WHILE USING THE RECALL CARTRIDGE.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R