BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200697 · Received July 1, 2013

    Report

    Report Number
    2531779-2013-09443
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/27/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL WERE DELIVERED ON (B)(6) 2013. NO ALARMS RELATED TO THE COMPLAINT WERE NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE TOTAL DAILY DOSE RECORD SHOWED THAT THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. DURING TESTING, THE FORCE SENSOR CALIBRATION WAS FOUND NOT TO BE WITHIN REQUIRED SPECIFICATIONS. THE FORCE SENSOR RESISTANCE WAS WITHIN SPECIFICATIONS. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: MOM REPORTS BLOOD GLUCOSE (BG) HAS BEEN RUNNING HIGH PAST 2 DAYS, HAS GOTTEN UP TO 539 MG/DL WITH MODERATE TO LARGE KETONES, STOMACH PAIN AND NAUSEA. MOM STATES HER DAUGHTER STAYED HOME FROM SCHOOL YESTERDAY, WAS ABLE TO ATTEND SCHOOL TODAY. CONTACTED DIABETES EDUCATOR AT HEALTH CARE PROVIDER (HCP) OFFICE AND HAVE BEEN MAKING ADJUSTMENTS TO HER SETTINGS. MOM STATES, PER HCP RECOMMENDATIONS, SHE IS CALLING TO HAVE ANIMAS DETERMINE IF PUMP SEEMS TO BE FUNCTIONING PROPERLY. REVIEWED DATE/TIME, MOM CONFIRMED THEY ARE CORRECT. NO AIR BUBBLES NOTED IN CARTRIDGE OR TUBING, NO BLOOD IN TUBING REPORTED. PATIENT CHANGED INSET YESTERDAY, CHANGED SITE/SET/CARTRIDGE USING FRESH, UNEXPIRED BOTTLE OF INSULIN TODAY, DENIES ANY BENT CANNULAS. NO LEAKING AT CARTRIDGE OR SITE REPORTED, NO REPORTS OF REDNESS, SWELLING, PAIN OR DISCHARGE. PATIENT IS NOT ILL, MOM REPORTS 2 WEEKS SINCE LAST MENSTRUAL CYCLE. MOM STATES THE ONLY DIFFERENT MEDICATION THE PATIENT HAS TAKEN IS DIPHENHYDRAMINE, 25MG TODAY AND YESTERDAY. ADVISED MOM THAT BG READINGS DO RESPOND TO BOLUSES DELIVERED, AND THAT THERE IS NO INDICATION OF PUMP MALFUNCTION. MOM STATES SHE IS CALLING DIABETES EDUCATOR BACK TO NOTIFY OF FINDINGS AND TO DISCUSS BG ISSUES FURTHER. MOM APPRECIATIVE. PATIENT¿S CURRENT BG IS 271 MG/DL, NO SYMPTOMS REPORTED AT THIS TIME. PATIENT REMAINS ON PUMP THERAPY. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299469 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening