BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3210953 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09772
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/23/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ASSOCIATED ALARMS OBSERVED IN THE PUMP HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED WITH NO DELIVERY ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1UNIT PER HOUR RATE, AND NO ERRORS, ALARMS, OR WARNINGS OCCURRED DURING TESTING. THE PUMP WAS EXERCISED ON A 29 HOUR FLOW ACCURACY TEST WITH NO DELIVERY ISSUES OCCURRING. THE FORCE SENSOR RESISTANCE MEASUREMENT WAS FOUND TO BE OUT OF SPECIFICATION AND THE FORCE SENSOR WAS OUT OF CALIBRATION. THERE WAS EVIDENCE OF CONTAMINATION OBSERVED ON THE FORCE SENSOR. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, INDICATING THAT THEY HAVE BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS READING ¿HI¿ ON THEIR METER SINCE GOING THROUGH THE FULL BODY SCANNER AT THE AIRPORT. THE REPORTER INDICATED THAT THEY PREVIOUSLY PUT THE PUMP THROUGH THE X-RAY FOR LUGGAGE, BUT THE SECURITY AT THE AIRPORT SAID THEY COULD STAY CONNECTED IN THE FULL BODY SCANNER. THE USER GUIDE INSTRUCTS THE USER NO TO EXPOSE THE PUMP TO X-RAY. THE PATIENT CHANGED OUT THEIR INSULIN, INFUSION SITE AND SET, AND CHECKED THEIR BLOOD GLUCOSE WITH MULTIPLE METERS. THE REPORTER INDICATED THAT THE PATIENT HAS NOT EXPERIENCED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA, BUT THEY CONTINUE TO READ HI ON THE METER. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS RELATED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310920 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening