BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2063004 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02488
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201576 WERE CONFIRMED TO BE DEFECTIVE VIA RETAINS. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE ELEVATED FROM 200-300 MG/DL AND THAT THERE WAS A CARTRIDGE LEAKAGE ISSUE WITH LOT# B201576. THERE WAS NO REPORT OF SYMPTOMS OR MEDICAL INTERVENTION THAT WOULD SUGGEST ACUTE COMPLICATION OF DIABETES AT THE TIME OF CONCERN. IT WAS REPORTED THAT THE PATIENT HAD A COLD. THE PATIENT COULD NOT PROVIDE ANY DETAILS REGARDING DATE OF LEAKAGE OR HOW HIGH BLOOD GLUCOSE CORRELATED TO A CARTRIDGE LEAKAGE AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE PROVIDER CONCLUDED THAT THE PATIENT'S HIGH BLOOD GLUCOSE MAY HAVE BEEN DUE TO A SITE ISSUE OR NEED FOR CLINICAL INSULIN ADJUSTMENT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED CARTRIDGE LEAKAGE ISSUE. THE PATIENT'S BLOOD GLUCOSE OF 200-300 MG/DL WITHOUT ANY SYMPTOMS OR MEDICAL INTERVENTION DOES NOT MEET ANIMAS' CRITERIA OF 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 IR 1200 / 1250 / 2020/ OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR