BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082216 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05468
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S HISTORY WAS REVIEWED AND SHOWED THAT THE LAST BASAL DELIVERY WAS ON (B)(6) 2013. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE AND NO INSULIN DELIVERY INTERRUPTION OBSERVED IN THE HISTORY. THE TOTAL DAILY DOSE ADDED UP CORRECTLY, MATCHING THE USER¿S PROGRAMMED BASAL RATE TARGET. THE PUMP WAS PRIMED EXERCISED FOR (B)(4) ON (B)(4) BASAL PROGRAM SUCCESSFULLY WITH NO ¿PRIME ISSUE¿ WARNINGS OR DELIVERY INTERRUPTION OCCURRING DURING THE TEST. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATION. THE PUMP PASSED A (B)(4) FLOW ACCURACY TEST SUCCESSFULLY. THE COVER WAS REMOVED AND NO MOISTURE INGRESS WAS FOUND IN SIDE THE PUMP. THE PRINTED CIRCUIT BOARD WAS NOT FOUND TO HAVE ANY INTERMITTENT CONDITION. THE FORCE SENSOR FLEX PINS WERE FOUND INTACT AND SECURED TO THE PRINTED CIRCUIT BOARD. THE ISSUE OF INACCURATE INSULIN DELIVERY WAS NOT DUPLICATED DURING THE INVESTIGATION. NO DEFECT WAS FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: MOM REPORTS PATIENT'S BLOOD GLUCOSE (BG) RANGED FROM 300 TO 600 MG/DL SINCE (B)(6) 2013. SHE HAS NOT CHECKED KETONES, CONFIRMS NAUSEA/VOMITING, ABDOMINAL CRAMPS, IRRITABLE, COMBATIVE, MODERATE INCREASED URINATION AND INCREASED THIRST. MOM REPORTS ON (B(6) 2013 GAVE INJECTIONS OF HUMALOG THROUGH THE DAY WITH PEN AND BG WOULD COME DOWN TO NORMAL. KEPT CHANGING SITE/SET (6 TIMES )SINCE SATURDAY MORNING. MOM CONFIRMS NO ABNORMALITIES AT THE SITE, DENIES KINKS OR OPACITIES IN TUBINGS OR CANNULAS. DENIES LOSS OF POWER, BLANK SCREENS OR LOSS OF PRIMES. NO ASSOCIATED ALARMS IN THE HISTORY. FIRST AND SECOND ALARMS IS LOW CARTRIDGE (B)(6) 2013. MOM CONFIRMS ALL SETTINGS ARE CORRECT. TIME/DATE SET CORRECT. ON (B)(6) 2013,DISCONNECTED PUMP, BUT DID NOT CONTACT ANIMAS OR A HEALTH CARE PROVIDER (HCP). MOM NOTICED WHEN PRIMING PUMP NEVER SAW INSULIN COMING OUT OF ANY OF THE TUBING. HAD MOM PRIME 10 UNITS OF INSULIN USING LAST TUBING ATTACHED TO THE CARTRIDGE IN THE PUMP. MOM CONFIRMED SAW 1 SMALL DROP, DENIED DIFFERENCE IN MOTOR SOUND. HAD MOM DO A 10 UNITS BOLUS, MOM SAW ONE VERY SMALL DROP AT THE END OF THE TUBING., AGAIN NO DIFFERENCE IN MOTOR SOUND. ON (B)(6) 2013 MOM REPORTS WAS GIVING INJECTIONS BY PEN EVERY 4 HRS WITH PUMP ON TO KEEP BG DOWN. BG ON (B)(6) 2013 AM WAS 407 MG/DL GAVE INJECTION BY PEN AND IN 3 HRS BG WAS DOWN TO NORMAL. PATIENT HAS BEEN SICK WITH A COLD FOR THE LAST COUPLE OF WEEKS, BUT BG COMES DOWN WITH INJECTIONS. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED TO CONTACT HCP FOR RECOMMENDATIONS ON THE ALTERNATE FORM OF INSULIN DELIVERY; TO REMAIN ON ALTERNATE FORM OF DELIVERY UNTIL REPLACEMENT PUMP ARRIVES AND CONTACT HCP. ADVISED MOM IN THE FUTURE TO CALL CTS IMMEDIATELY WITH ANY ISSUES WITH PUMP OR SUPPLIES THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA ALLEGEDLY RELATED TO PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184932 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening