BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2212823 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05923
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED UNACKNOWLEDGED ALARMS AND WARNINGS PRIOR TO THE REPORTED EVENT DATE, CAUSING INACCURACIES IN THE TOTAL DAILY BASAL DELIVERIES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES OCCURRING. AN EZPRIME OPERATION WAS PERFORMED WITH NO ISSUES. TEST BOLUSES WERE PERFORMED DURING TESTING AND WERE CORRECTLY CALCULATED AN ACCURATELY RECORDED IN THE PUMP HISTORY. THERE WERE NO INSULIN DELIVERY DEFECTS FOUND ON INVESTIGATION. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2011 TO REPORT SHE HAD BEEN HOSPITALIZED TWICE IN A 3 WEEK PERIOD FOR LOW BLOOD GLUCOSE (BG) AND HER DOCTOR FELT PUMP MAY HAVE CAUSED/CONTRIBUTED TO LOW BG. THE PATIENT DID NOT RECALL DATE OF FIRST HOSPITALIZATION AND DID NOT PROVIDE ANY DETAILS REGARDING THE HOSPITALIZATION OTHER THAN SHE WAS DISCHARGED AFTER 6 DAYS. ON (B)(6) 2011, THE PATIENT CLAIMED HER BG DROPPED TO 30 MG/DL. EMERGENCY SERVICES WAS CONTACTED AND THE PATIENT REPORTED BEING TREATED WITH GLUCOSE AND FOOD. THE PATIENT CONFIRMED SHE REMAINED HOME AND WAS NOT TAKEN TO THE HOSPITAL FOR FURTHER TREATMENT. ON THE FOLLOWING MORNING, THE PATIENT STATED THAT HER SPOUSE FOUND HER "THRASHING ABOUT IN THE BED" AND UNRESPONSIVE. EMERGENCY SERVICES WAS CONTACTED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT REPORTED HER BG WAS 15 MG/DL AT THE TIME OF HER ARRIVAL TO THE HOSPITAL AND WAS TREATED WITH IV GLUCOSE. THE PATIENT STATED SHE WAS ADMITTED FOR 2 DAYS AND HAS BEEN ON BACK-UP PLAN (INJECTIONS) SINCE BEING DISCHARGED. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT NOTED THAT THE SUBJECT PUMP WOULD NOT POWER ON AND THEREFORE PUMP SETTINGS COULD NOT BE REVIEWED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY HOSPITALIZED AND TREATED FOR SEVERE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    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 66 YR