BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2032294 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01875
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HISTORY FOR THE AVAILABLE DATE RANGE SHOWED ONE UNEXPLAINED POWER EVENT. THE PUMP CASING WAS OBSERVED TO HAVE A CRACK IN THE BATTERY COMPARTMENT. THE BATTERY CAP RETURNED WITH THE PUMP WAS OBSERVED TO HAVE STRIPPED THREADS AND WAS UNABLE TO SECURE APPROPRIATELY TO THE PUMP. A TEST CAP WAS INSERTED TO COMPLETE TESTING. THE PUMP POWERED ON AND WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS CONFIRMED TO BE DELIVERING WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR OTHER DAMAGE WAS OBSERVED TO THE POWER CIRCUIT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/29/2014 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE KEYPAD SYMBOLS WERE WORN AND DISPLAY LENS WAS SCRATCHED.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED THAT ON (B)(6) 2011 AT 7:00 PM, THE INSULIN PUMP REBOOTED POWER, AND SHE VIEWED THE VERIFICATION SCREEN ON THE DISPLAY. THE SELF-REBOOT ALSO OCCURRED DURING THE NIGHT, WHILE HE PT WAS ASLEEP. AT AN UNSPECIFIED TIME AFTERWARDS, THE PT OBTAINED THE BLOOD GLUCOSE READING OF 'HI MG/DL' (GREATER THAN 600 MG/DL), AND HAD TRACE URINARY KETONES. AT THAT TIME, THE PT EXPERIENCED THE SYMPTOM OF NAUSEA. THE PT'S MOTHER PROVIDED A CORRECTION BOLUS AFTER THE PUMP WAS REBOOTED. THE PT DID NOT SEEK ANY MEDICAL ATTENTION. ON (B)(6) 2011, THE PT'S FASTING BLOOD GLUCOSE LEVEL WAS WITHIN HIS TARGET RANGE OF 170 MG/DL TO 210MG/DL; THE REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC RESULT. TROUBLESHOOTING REVEALED THE REPORTER HAD REPLACED THE PUMP'S BATTERY, THE BATTERY CAP WAS ON TIGHT AND SECURE, NO CRACK WERE SEEN IN THE BATTERY COMPARTMENT, NO DAMAGE SEEN TO THE THREADS, THE SPRING AND METAL CONTACTS WERE INTACT, THE DATE/TIME WAS CORRECT , AND THE BASAL AND BOLUS SETTINGS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R