BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001559 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02643
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED THAT ON (B)(6) 2013, THE TOTAL DAILY DOSE (TDD) ADDS UP CORRECTLY FOR THE USER'S PROGRAM AND INDICATES A TEMPORARY BASAL PROGRAM WAS RUNNING THAT DAY. ON INVESTIGATION, THE PUMP WAS EXERCISED FOR 29 HOURS. THE TDD CORRECTLY REFLECTED THE PROGRAMMED BASAL RATE. BOLUSES WERE PERFORMED AND WERE CORRECTLY RECORDED IN THE PUMP HISTORY. FORCE SENSOR CALIBRATION TESTING SHOWED THE FORCE SENSOR WAS NOT DETECTING THE CORRECT FORCE AT 5 LBS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATION. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT. THE PUMP WAS FOUND TO BE DELIVERING INSULIN AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE ADDITIONAL FINDINGS: FORCE SENSOR CALIBRATION TESTING SHOWED THE FORCE SENSOR WAS NOT DETECTING THE CORRECT FORCE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS HAVE BEEN R ELEVATED, IN THE 300 MG/DL RANGE, WITH OCCASIONAL 400 MG/DL AND ONE 500 MG/DL ABOUT TWO WEEKS AGO. THE PATIENT HAS BEEN TO THE ENDOCRINOLOGIST, WHO IS INCREASING BASAL RATE TEMPORARY FOR 24 HOURS HRS AT A TIME UNTIL BG START COMING DOWN. MOM REPORTS ON ONE OCCASION, PATIENT HAD SMALL TO MODERATE, KETONES, NAUSEA BUT NO VOMITING, DENIES ABDOMINAL CRAMP, SHORTNESS OF BREATH, OR CHEST PAINS. MOM CONFIRMED MODERATE INCREASED URINATION, MODERATE INCREASED THIRST, AND TIREDNESS. MOM HAS CHANGED OUT VIALS INSULIN. MOM GAVE 20 UNITS OF HUMALOG PER PROTOCOL AND BG CAME DOWN TO NORMAL MOM DENIES ISSUES WITH SITE, DENIES LEAKAGE OF CARTRIDGE, OR SITE: DENIES BLOOD IN THE TUBING OR CANNULA: DENIES BENT OR KINKED CANNULA. PATIENT USES THE ABDOMEN AND ROTATES FROM SIDE TO SIDE (NO SCAR TISSUE) BUT STAYING IN THE SAME AREA,. MOM CONFIRMS GROWTH SPURT (GREW 3 INCHES, SINCE (B)(6) 2012, AND AN INCREASE IN CHILD'S STRESS LEVEL DUE TO AN UNSTABLE FAMILY SITUATION. DENIES ILLNESS. MOM CONFIRMED PATIENT KNOWS HOW TO CARBOHYDRATE COUNT BUT DOES NOT ALWAYS DO THE ADDITION CORRECTLY. PATIENT ALSO DISCONTINUES PUMP DURING PHYSICAL EDUCATION CLASS AT TIMES AND DOES NOT TAKE MISSED BASAL RATE INSULIN. PATIENT'S CURRENT BG IS 320 MG/DL WITH NO SYMPTOMS. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEW OF PUMP INDICATE TIME/DATE IS SET CORRECT. REVIEW OF PUMP INDICATES THE TEMPORARY BASAL WAS SET BUT WAS INTERRUPTED AND NOT RESET. REVIEW OF THE TDD INDICATES AN INCREASE OF APPROXIMATELY 10+UNITS OF BASAL TOTAL ON (B)(6) 2013, WITH NO TEMPORARY RATE AND NO SUSPEND RECORDED. BUT THE BASAL HISTORY INDICATES TEMPORARY BASAL WAS SET. ALL OTHER BASAL TOTALS ARE WITHIN RANGE AND CORRELATES TO HISTORY BASAL. THE PATIENT IS NOT SETTING TEMPORARY EVERYDAY AS PER ENDOCRINOLOGIST ORDER. REVIEW OF THE PRIME HISTORY INDICATES THE PATIENT IS NOT FILLING CANNULA, NOT ALWAYS CHANGING TUBING (DUE TO USING SO MUCH INSULIN) AND POSSIBLY NOT CHANGING SITE 7 DAYS. HOWEVER, PATIENT TELLS MOM HE CHANGES SITE EVERY 3 DAYS AS INSTRUCTED. CTS ADVISED MOM TO REINFORCE TO PATIENT THE IMPORTANCE OF FILLING CANNULA AND CHANGING SITE EVERY 3 DAYS. ADVISED MOM WHEN GOING INTO PUMP TO PRIME, CHANGE SITE/SET OR WHEN BATTERY CAP IS REMOVED, THE PUMP CANCELS OUT THE TEMPORARY BASAL OR COMBO BOLUS. ADVISED MOM THE PUMP SAFE TO USE. PATIENT IS CONTINUING ON PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR OF NOT CHANGING SUPPLIES PER INSTRUCTIONS FOR USE, AND NOT FILLING THE CANNULA WHEN PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105950 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening