BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3140550 · Received May 31, 2013

    Report

    Report Number
    3008382007-2013-14040
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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) 2013 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 AT 6:00 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 449 MG/DL, 112 MG/DL, 210 MG/DL, 31 MG/DL AND 202 MG/DL ON THE REPORTED METER OVER A TIME PERIOD GREATER THAN 20 MINUTES. THE PATIENT TOOK NO ACTIONS BASED ON THESE READINGS. THIRTY MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SLURRED SPEECH AND CONFUSION. AT 11:30 AM THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM, WHERE HE RECEIVED THE TREATMENT OF FOOD AND DRINK AND GLUCOSE TABLETS. DURING THE TROUBLESHOOTING TELEPHONE CALL, A QUALITY CONTROL TEST WAS PERFORMED WITH PASSING RESULTS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS SUGGESTING SEVERE HYPOGLYCEMIA AFTER OBTAINING ELEVATED METER READINGS, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH FOOD AND GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240710 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3317741

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Life Threatening| R