BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3183550 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-17997
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIO IQ METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO AN UNKNOWN METER AND AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED, THE ALLEGED ISSUE OCCURRED 1 MONTH PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING READINGS OF ¿300MG/DL¿ ON THE LFS METER COMPARED TO ¿118MG/DL¿ ON ANOTHER UNKNOWN METER. THE PATIENT REPORTED USING NOVOLOG ON A SLIDING SCALE TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 HE INCREASED HIS USUAL DOSE OF MEDICATION TO 15 UNITS AND DELAYED EATING AND THEN ANOTHER 5 UNITS OF LANTUS INSULIN WAS ADMINISTERED AT AN UNKNOWN TIME. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. HOWEVER, THE PATIENT REPORTED ON (B)(6) 2013 AT AN UNKNOWN TIME, THE PATIENT WAS TREATED BY EMS. AFTER A READING OF ¿47MG/DL¿ WAS OBTAINED ON THE EMS METER, THE PATIENT WAS GIVEN A GLUCAGON INJECTION. THE PATIENT REPORTED AN ADDITIONAL READING OF ¿200MG/DL¿ WAS OBTAINED AFTER THE GLUCAGON INJECTION WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS FOUND TO BE USING AN INCORRECT TESTING PROCESS, THE PATIENT DID NOT WASH HIS HANDS PRIOR TO TESTING. THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED INACCURATE HIGH READING, HE INCREASED HIS USUAL MEDICATIONS AND DELAYED EATING THEREFORE REQUIRING TREATMENT FROM A HEALTHCARE PROFESSIONAL FOR A LOW BLOOD GLUCOSE READING. THIS INCIDENT DESCRIPTION CONTAINS INFORMATION FROM RELATED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284269 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R