BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1873111 · Received October 15, 2010

    Report

    Report Number
    2531779-2010-01632
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    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. THE PATIENT STATES HER BLOOD GLUCOSE WAS 94MG/DL AT 7PM ON (B)(6)2010. AT 7:30PM SHE FELT SHE WAS GETTING A HOT FLASH AND HER BLOOD GLUCOSE WAS GOING TOO HIGH. SHE TESTED HER BLOOD GLUCOSE AND IT WAS 315MG/DL. SHE BOLUSED TO CORRECT HER BLOOD GLUCOSE AND HER SUBSEQUENT READINGS WERE 226MG/DL, 215MG/DL, 209MG/DL, 200MG/DL, 205MG/DL, 201MG/DL, 200MG/DL, 232MG/DL. THE FINAL BEING AT 10PM. THE PATIENT THEN DECIDED TO GO OFF THE PUMP AND GO TO THE ER. THE PATIENT STATED THAT THEIR BLOOD GLUCOSE LEVELS WERE GOING LOW; HOWEVER, HER BG READINGS DID NOT INDICATE THAT SHE WAS GOING LOW. THE PT STATES SHE WAS DIAGNOSED WITH A BLADDER INFECTION WHILE IN THE EMERGENCY ROOM.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HER BLOOD GLUCOSE LEVELS HAVE BEEN RUNNING LOW AND SHE HAD BEEN IN THE HOSPITAL THREE TIMES IN THE PAST WEEK. THE PATIENT REPORTS HER BLOOD GLUCOSE LEVELS SEEM TO DROP TOO FAST. SHE REPORTS HER BLOOD GLUCOSE DROPPED TO 55MG/DL IN THE PAST WEEK. SHE REPORTS AFTER BOLUSING, SHE EXPERIENCES A BURNING SENSATION AND VOMITS. ON (B)(6)2010, THE PATIENT WENT TO THE EMERGENCY ROOM BUT WAS NOT ADMITTED AND WAS DISCHARGED 2 HOURS LATER. THE PATIENT WAS NOT WEARING THE PUMP AT THE TIME OF ARRIVAL TO THE HOSPITAL. THE PATIENT STATES HER BLOOD GLUCOSE WAS 94MG/DL AT 7PM ON (B)(6)2010. AT 7:30PM, SHE FELT SHE WAS GETTING A HOT FLASH AND HER BLOOD GLUCOSE WAS GOING TOO HIGH. SHE TESTED HER BLOOD GLUCOSE AND IT WAS 315MG/DL. SHE BOLUSED TO CORRECT HER BLOOD GLUCOSE AND HER SUBSEQUENT READINGS WERE 226MG/DL, 215MG/DL, 209MG/DL, 200MG/DL, 205MG/DL, 201MG/DL, 200MG/DL, 232MG/DL. THE FINAL BEING AT 10PM. THE PATIENT THEN DECIDED TO GO OFF THE PUMP AND GO TO THE ER. THE PATIENT STATES SHE WAS DIAGNOSED WITH A BLADDER INFECTION WHILE IN THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R