BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2122255 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04092
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    February 23, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2011. THE REPORTER STATED THAT THE PATIENT EXPERIENCED NAUSEA, EMESIS, AND SHORTNESS OF BREATH; BLOOD GLUCOSE UPON ADMISSION WAS 955 MG/DL. HE STATED THAT THE INITIAL TREATMENT INCLUDED INTRAVENOUS INSULIN AND VANCOMYCIN ADMINISTRATION. THE REPORTER ALLEGED THAT THE PATIENT EXPERIENCED ASPIRATION PNEUMONIA AS THE RESULT OF THE EMESIS. IT WAS REPORTED THAT SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE REPORTER CLAIMED THAT THE PATIENT WAS USING A CARTRIDGE FROM RECALLED LOT #B201583 AT THE TIME OF THE EVENT. HE DID NOT REPORT EVIDENCE OF INSULIN LEAKAGE FROM THE CARTRIDGE; INSULIN ON THE OUTSIDE OF THE CARTRIDGE OR INSIDE THE CARTRIDGE COMPARTMENT WAS NOT MENTIONED. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS HOSPITALIZED FOR DKA WHILE USING A CARTRIDGE FROM A RECALLED LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization