BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3935322 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17445
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 30, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/25/2014).THE PATIENT¿S METER HAS BEEN RETURNED ON 7/14/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/16/2014 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. TEST STRIP LOT#: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6), 2014 THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 480 MG/DL AND 370 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WERE INACCURATELY HIGH COMPARED TO HIS EXPECTED VALUES. BASED ON THESE ELEVATED METER READINGS, THE PATIENT TOOK THE ACTION OF TAKING 20.0 UNITS NOVOLOG INSULIN. TWO HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF RAPID HEARTBEAT, DIZZINESS, SHAKING AND SWEATING. THE PATIENT DID NOT REPORT ADMINISTERING ANY SELF-TREATMENT FOR THESE SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON ELEVATED METER READINGS, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413818 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening