BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 3800120 · Received May 8, 2014

    Report

    Report Number
    2939301-2014-10652
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    May 5, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (06/03/2014), THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT IN GERMANY CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRAEASY METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2014 THE TECHNICAL SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER THE PATIENT WAS UNABLE/UNWILLING TO PROVIDE VERY MANY SPECIFIC DETAILS OF THE INCIDENT. ON TWO SEPARATE UNSPECIFIED DATES, THE PATIENT REPORTEDLY OBTAINED AN ELEVATED METER READING ON THE REPORTED METER. THE PATIENT WAS UNABLE TO PROVIDE THE SPECIFIC RESULT. THE PATIENT NOTED HIS EXPECTED READINGS RANGE FROM 180 MG/DL TO 210 MG/DL. BASED ON THE METER READINGS, THE PATIENT TOOK AN INCREASED DOSE OF NOVORAPID INSULIN; HE WAS UNABLE TO PROVIDE THE SPECIFIC NUMBER OF UNITS INSULIN TAKEN. AT 2:00 AM ON THE FIRST INCIDENT, AND AT 5:00 AM ON THE SECOND INCIDENT, THE PATIENT EXPERIENCED THE SAME SYMPTOMS OF RAPID HEARTBEAT AND HOT FLASHES. WHILE SYMPTOMATIC, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL WITH THE REPORTED METER AND OBTAINED THE READINGS OF 48 MG/DL AND 52 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS AND FELT BETTER AFTERWARDS; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT MANAGES HIS DIABETES WITH NOVORAPID INSULIN TAKEN ON A SLIDING SCALE AND 26.0 UNITS LEVEMIR INSULIN DAILY. THE PATIENT TESTS HIS BLOOD GLUCOSE LEVEL FIVE TIMES PER DAY. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN ELEVATED METER READING, AND RECEIVED TREATMENT WITH GLUCOSE TO ALLEVIATE HIS SYMPTOMS. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279547 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R