BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4771676 · Received May 14, 2015

    Report

    Report Number
    2531779-2015-16036
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 30, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    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: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/23/2015 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN HAS A PINKISH CONTRAST. REVIEW OF THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTS USER'S PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO ALARMS OCCURRED DURING 24 HRS DURATION TESTING. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER PAD AND ON THE SIDE AT THE THREADS. BATTERY CAP/CARTRIDGE CAP WERE NOT RETURNED; TEST CAPS USED TO COMPLETE TESTING. 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PUMP HAD A DIM DISCOLORED DISPLAY. THE PATIENT HAD A BLOOD GLUCOSE (BG) LESS THAN 70 MG/DL WITH DIZZINESS, CONFUSION, AND AN UNSTEADY GAIT. THE PATIENT WAS UNSURE OF THE BG IN THE MIDDLE OF THE NIGHT, BUT AT (B)(6) 2015 6:30AM IT WAS 137 MG/DL AND THEN 172 MG/DL. PATIENT REQUIRED NO UNUSUAL TREATMENT. THIS COMPLAINT IS BEING REPORTED AS THE DIM DISPLAY ISSUE WAS NOT RESOLVED, AND THE PATIENT EXPERIENCED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317293 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening