BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2508217 · Received March 28, 2012

    Report

    Report Number
    2531779-2012-02542
    Event Type
    Injury
    Date Received
    March 28, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. RECALL 2531779-03/24/2010/003-R.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WERE NO ALARMS NOTED RELATED TO THE COMPLAINT IN THE PUMP ALARM HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. UNRELATED TO THE REPORTED ADVERSE EVENT, THE "EZPRIME" OPERATION WAS PERFORMED AND DURING THE "LOAD" STEP THE PUMP DID NOT DETECT THE CARTRIDGE AND PUSHED ALL THE FLUID OUT. THE PUMP ALSO EMITTED A "NO CARTRIDGE DETECTED" WARNING DURING TESTING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND THE FORCE SENSOR PINS AND LED DISPLAY WERE FOUND TO BE INTACT. A REVIEW OF THE BLACK BOX HISTORY SHOWS NO LOSS OF PRIME WARNINGS WITH ZERO FORCE OR "NO CARTRIDGE DETECTED" WARNINGS. FURTHER INVESTIGATION WAS NOT ABLE TO BE COMPLETED DUE TO THE PUMP NOT DETECTING THE CARTRIDGE. UNRELATED THE COMPLAINT, THE BATTERY CAP WAS FOUND TO BE DAMAGED AND THE PUMP WOULD NOT POWER ON APPROPRIATELY. A TEST CAP WAS USED FOR TESTING PURPOSES. THE PUMP WAS BOOTED AND THE VERIFY SCREEN WAS DISPLAYED WITH THE APPROPRIATE AUDITORY AND VIBRATORY ALARMS. THE DISPLAY SCREEN WAS ALSO FOUND TO HAVE A REDDISH TINT. A TEST DISPLAY WAS INSERTED WITH NO REDDISH TINT WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP. THE PATIENT CLAIMED THAT THIS ISSUE HAD OCCURRED MULTIPLE TIMES FOR THE PREVIOUS 2 MONTHS. DURING THE TIME OF CONCERN, THE PATIENT CLAIMED THAT HE HAD SUFFERED HYPOGLYCEMIC AS WELL AS HYPERGLYCEMIC EPISODES. IN SOME HYPOGLYCEMIC EVENTS, THE PATIENT ALLEGED THAT HE HAD DEVELOPED SYMPTOMS OF SHAKINESS AND SWEATING. THE PATIENT ADMINISTERED SELF-CARE BY EATING SOMETHING, DRINKING JUICE, AND/OR CONSUMING GLUCOSE TABLETS. WITH THE HYPERGLYCEMIC EVENTS, THE PATIENT ADMINISTERED SELF-CARE BY TAKING INSULIN VIA INJECTION WHEN NEEDED. THE PATIENT COULD NOT RECALL IF HE HAD EVER GOTTEN A NO CARTRIDGE DETECTED ALARM. IN SOME CASES DURING THE LOAD STEP, THE PATIENT CLAIMED THAT THE PUMP'S MOTOR WOULD NOT MOVE WHICH CAUSED HIM TO REPEAT THE STEP. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP PUSHED INSULIN OUT DURING THE LOAD STEP. IN ADDITION, THE PATIENT CLAIMED THAT DURING THE TIME OF CONCERN, HE HAD DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    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 Life Threatening