BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6041981 · Received October 19, 2016

    Report

    Report Number
    2531779-2016-29130
    Event Type
    Injury
    Date Received
    October 19, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. USER ERROR SHOULD BE CONSIDERED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/13/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2016 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS VERIFIED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING TESTING. THE BLACK BOX SHOWS A POWER ON RESET(POR) AFTER A REPLACE BATTERY ALARM ON (B)(6) 2016 05:31. TWO UNEXPLAINED POR EVENTS THEN FOLLOWED. PUMP WAS POWERED BACK ON AND THE TIME/DATE WAS SET TO (B)(6) 2007 11:53 AND DELIVERIES RESUMED.. AN UNEXPLAINED POR OCCURRED ON (B)(6) 2007 21:02. PUMP WAS POWERED BACK ON AND A MANUAL TIME/DATE CHANGE WAS MADE FROM (B)(6) 2016 21:04 TO (B)(6) 2016 21:44..#3. NO DAMAGE FOUND TO RETURNED BATTERY CAP. BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER PAD. RETURNED BATTERY CAP IS ABLE TO FULLY ATTACH TO THE PUMP. PUMP BOOTS TO THE VERIFY SCREEN WITH AUDIBLE & VIBRATORY FEATURES.. A 24 HR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH RETURNED BATTERY CAP; NO POR¿S WERE DUPLICATED DURING THIS TIME.. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. REMOVED PUMP COVER; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. 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) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA, - LARGE KETONES, BLOOD GLUCOSE > 500 MG/DL) WITH NAUSEA, VOMITING ON (B)(6) 2016. IV FLUIDS, FOOD AND/OR DRINK WERE PROVIDED AS TREATMENT. DURING TROUBLESHOOTING, THE REPORTER ALLEGED THAT A 'NO POWER' ISSUE HAD BEGUN ON (B)(6) 2016. THERE WAS NO VISIBLE DAMAGE OR CORROSION ON THE PUMP. THE ALARM HISTORY INDICATED THAT A REPLACE BATTERY ALARM LED TO THE POWER LOSS/REBOOTING. CUSTOMER SUPPORT ADVISED THE REPORTER TO CHANGE TO A NEW BATTERY FROM A NEW PACK, AND THE PUMP POWERED ON APPROPRIATELY. THIS COMPLAINT IS BEING REPORTED AS THE USER ERROR HAD RESULTED IN DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691933 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR