BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140222 · Received June 25, 2011

    Report

    Report Number
    2531779-2011-04460
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    April 2, 2011
    Report Date
    May 28, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE ALARMS NOTED IN THE PUMP HISTORY ARE INDICATIVE OF TYPICAL PUMP USE. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES FOUND. THERE WAS NO EVIDENCE OF LEAKAGE IN THE CARTRIDGE COMPARTMENT. THERE WAS NO DEFECT FOUND ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. 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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 PATIENT REPORTED THAT ON (B)(6) 2011 HE WAS SENT TO THE EMERGENCY ROOM BY HIS HEALTHCARE PROVIDER (HCP) FOR A BLOOD GLUCOSE (BG) READING OF "HI" (GREATER THAN 600 MG/DL) AND AN ELEVATED BLOOD PRESSURE. THE PATIENT REPORTED NO PRESENCE OF KETONES. THE PATIENT STATED THAT HE WAS ADMITTED AND HE REMAINED ON THE PUMP WHILE IN THE HOSPITAL BUT HIS BASAL RATES WERE INCREASED FROM 13 UNITS TO 20.3 UNITS PER DAY. HE REPORTED THAT HE WAS DISCHARGED ON (B)(6) 2011 WITH A BG OF ABOUT 300 MG/DL. THE PATIENT NOTED THAT HIS BGS HAVE REMAINED OVER 200 MG/DL SINCE THE HOSPITALIZATION. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE TOTAL DAILY DOSE MATCHES PROGRAMMED BASAL AND BOLUS DELIVERY. THE PATIENT REPORTED THAT HIS HCP HAD ADVISED HIM TO CHANGE HIS INSULIN SENSITIVITY FACTOR (ISF) TO 25; A REVIEW OF THE PUMP HISTORY INDICATED THAT THE ISF SETTING HAD NOT BEEN CHANGED AS RECOMMENDED. THE PATIENT CONFIRMED THAT HE CHANGED THE CARTRIDGE WITHIN AN HOUR OF RECEIVING AN "EMPTY CARTRIDGE" ALARM. THE PATIENT CONFIRMED THAT TIME AND DATE SETTINGS ON THE PUMP WERE CORRECT, AND THAT THERE WERE NO AIR BUBBLES IN THE CARTRIDGE OR THE TUBING. HE REPORTED ONE EPISODE OF LEAKAGE AT THE SITE, AND STATED THAT HE CHANGED THE SITE IMMEDIATELY. THE PATIENT STATED THAT HE ROTATED SITES EVERY DAY AND A HALF TO FOUR DAYS AND USES HIS ABDOMEN FOR SITES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR