BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3900550 · Received June 27, 2014

    Report

    Report Number
    2939301-2014-15691
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    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 HEALTHCARE PROFESSIONAL/REPORTER IN (B)(6), A PHARMACIST, CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2014 THE TECHNICAL SERVICE REPRESENTATIVE SPOKE WITH THE REPORTER TO OBTAIN AND VERIFY INFORMATION. ON THE MORNING OF (B)(6) 2014, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 151 MG/DL ON THE REPORTED METER, WHICH WAS HIGHER THAN HIS USUAL RANGE OF 110 MG/DL TO 120 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH NOVOMIX INSULIN 28-30 UNITS IN THE MORNING, 40 UNITS AT NOON AND 50 UNITS IN THE EVENING. AFTER THE PATIENT HAD TAKEN HIS DOSE OF 50.0 UNITS NOVOMIX INSULIN, THE PATIENT EXPERIENCED THE SYMPTOMS OF WEAKNESS, SWEATING AND IMPAIRED VISION. AT 7:00 PM WHILE SYMPTOMATIC, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 200 MG/DL ON THE REPORTED METER. AT 7:20 PM, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL USING HIS WIFE¿S ONETOUCH ULTRA METER AND OBTAINED THE READING OF 60 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING JAM; HE DID NOT SEEK ANY MEDICAL ATTENTION. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED METER READING EARLIER IN THE DAY AND CONTINUING TO TAKE HIS INSULIN DOSES, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378081 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR