BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2880003 · Received December 19, 2012

    Report

    Report Number
    2531779-2012-14860
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: (B)(6) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED NO SIGNS OF POWER LOSS. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP FULLY SECURED TO THE PUMP AND THE PUMP POWERED ON APPROPRIATELY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS; NO POWER EVENTS OCCURRED DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED. A TEST SCREEN WAS INSERTED AND THE PUMP DISPLAY RETURNED TO NORMAL.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE WAS IN THE HOSPITAL FOR DIABETIC KETOACIDOSIS. THE PATIENT STATED THAT SHE IS ON A BACK-UP PLAN FOR INSULIN DELIVERY DUE TO THE PUMP REBOOTING AND LOSING POWER. THE PATIENT STATED THAT THE REBOOTING BEGAN "A FEW DAYS AGO." THE PATIENT REPORTEDLY EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) OF 771MG/DL WITH SHAKINESS, MEMORY LOSS, CONFUSION, SLURRED SPEECH, AND KETONES. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF THE INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT WAS ABLE TO REACH THE PATIENT TO COMPLETE TROUBLESHOOTING ON (B)(6) 2012. THE PATIENT REPORTED THAT SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012, WAS IN ICU FOR THREE DAYS, AND THEN WAS IN A REGULAR HOSPITAL ROOM FOR TWO MORE DAYS. THE PATIENT STATED THAT SHE IS ON CHEMOTHERAPY AND THAT WHEN HER BG FIRST BEGAN TO ELEVATE, SHE ATTRIBUTED IT TO THE CHEMOTHERAPY. THE PATIENT STATED THAT UPON ADMITTANCE TO THE HOSPITAL, HER BG WAS BETWEEN 800 AND 1000MG/DL, AND LATER HER BG READ 770MG/DL ON THE HOSPITAL METER. THE PATIENT STATED THAT SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT STATED SHE WAS RELEASED ON INSULIN INJECTIONS, AND HER MOST RECENT BG WAS AROUND 200MG/DL. THE PATIENT STATED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY PRIOR TO THE REPORTED BG INCIDENT. THE PATIENT DENIED ANY MOISTURE OR CORROSION INSIDE THE PUMP. THE PATIENT STATED THAT THE BATTERY CAP IS NEW AND THE YELLOW O-RING WAS NOT VISIBLE. THE PATIENT DENIED DAMAGE TO THE PUMP CASING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED SEVERE HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION RELATED TO A POWER ISSUE WITH THE PUMP.

    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 66 YR Hospitalization| L| R