BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2518418 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02836
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    November 5, 2011
    Report Date
    March 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON 03/07/2012 REPORTING THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2011. THE REPORTER STATED THAT THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS AND KIDNEY FAILURE. THE REPORTER CONFIRMED THAT THE PATIENT WAS WEARING THE PUMP AT THE TIME OF DEATH AND THAT THE PUMP WAS STILL RUNNING WHEN REMOVED FROM THE PATIENT BY THE CORONER. THE REPORTER STATED THAT ON (B)(6) 2011 THE PATIENT WAS SICK WITH WHAT THEY BELIEVED WAS THE FLU. THE REPORTER STATED THAT THE PATIENT'S METER REVEALED BLOOD GLUCOSE READING OF 600 + MG/DL. THE REPORTER STATED THAT PATIENT TOLD HER THAT HE WOULD BE FINE AND DID NOT GO TO A HOSPITAL. THE PATIENT WAS REPORTEDLY VOMITING AT AROUND 2:00 PM AND TOLD THE REPORTER THAT HE STARTED FEELING BETTER BY 11:30 PM. THE PATIENT'S ROOMMATE REPORTEDLY FOUND THE PATIENT NOT BREATHING. THE REPORTER STATED THAT SHE WAS SURE THAT IT WAS NOT RELATED TO THE PUMP; THE REPORTER STATED THAT SHE WAS UNSURE ABOUT THE SITE AS IT WAS REMOVED BY THE CORONER. THE REPORTER STATED THAT SINCE THE PATIENT'S DEATH, ONE OF THE PATIENT'S FRIENDS HAS BEEN USING THE PUMP WITHOUT ANY KNOWN BLOOD GLUCOSE EXCURSIONS. THIS REPORT IS MADE BASED ON THE FOLLOWING CONCLUSION: THE PATIENT DIED OF DIABETIC KETOACIDOSIS AND KIDNEY FAILURE WHILE USING THE PUMP. ALTHOUGH NOT KNOWN, THERE IS THE POSSIBILITY THAT THE PATIENT'S DEATH MAY HAVE BEEN RELATED TO THE USE OF AN INSULIN PUMP, MALFUNCTION OR MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death