BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2882008 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14930
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. USER ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR TO THIS EVENT, AS THE PATIENT WAS NOT DISCONNECTED WHILE PRIMING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING SERIES OF EVENTS: LAST FRIDAY (B)(6) 2012 SHE WAS VERY ILL WITH BRONCHITIS, AND H ER SON WAS HELPING HER WITH HER PUMP . THE PUMP KEPT WARNING NOT PRIMED SO HER SON BEGAN PRIMING TO CLEAR THE WARNING. PUMP WAS PRIMED WITH TUBING ATTACHED . THE PATIENT REPORTS INADVERTENT INFUSIONS OF 56.2 U, 5.0 U AND 43.1U GIVEN ON (B)(6) 2012 WHEN PRIMING WHEN ATTACHED. SHE REPORTEDLY SHE FELL AND THEN HER SON TOOK HER TO THE ER. SHE WAS ADMITTED WITH A BLOOD GLUCOSE (BG) OF 32 MG/DL. SHE UNSURE OF EVENTS OF (B)(6) 2012 OTHER THAN HER SON TRYING TO HELP HER AND HE FORGOT TO DISCONNECT HER FROM THE PUMP. LOSS OF PRIME WARNING OCCURRED ABOUT 3 TIMES, AS PUMP WAS PRIMED 3 TIMES. THE CAUSE FOR THE LOSS OF PRIME IS UNKNOWN. THE PATIENT REPORTS FROM HOSPITAL THAT THE CARTRIDGE AND INFUSION SET HAVE BEEN CHANGED OUT AND PUMP IS WORKING AS DESIRED NOW. CUSTOMER SUPPORT (CTS) REVIEWED WITH HER TO ALWAYS DISCONNECT WHEN PRIMING, TO CALL CTS 24 /7 AND HER SON CAN CALL ALSO. THE PATIENT IS ON UNKNOWN MEDICATION FOR THE BRONCHITIS, AND IN HOSPITAL RECOVERING FROM THE BRONCHITIS AND BACK ON HER PUMP. THIS ISSUE IS BEING REPORTED DUE TO THE ALLEGATION THAT THE LOSS OF PRIME FOR AN UNKNOWN REASON CONTRIBUTED TO THE HYPOGLYCEMIA AND SUBSEQUENT HOSPITALIZATION. USER ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR TO THIS EVENT, AS THE PATIENT WAS NOT DISCONNECTED WHILE PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS IR 1000 CARTRIDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization