BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3881393 · Received June 18, 2014

    Report

    Report Number
    2939301-2014-14786
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    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
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A SALES REPRESENTATIVE CONTACTED LIFESCAN (LFS) (B)(4) AFTER SPEAKING WITH A PHARMACIST. THE PHARMACIST STATED THAT THEY SPOKE WITH THE LAY USER/PATIENT AND THEY ALLEGED THAT THE ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO A HOSPITAL METER. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVES (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2014. AT AN UNSPECIFIED DATE/TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿29.0 MMOL/L¿ WITH THE SUBJECT METER AND ¿16.0 MMOL/L¿ WITH A HOSPITAL METER, PERFORMED WITHIN AN UNSPECIFIED TIME OF EACH OTHER. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HIS DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE REPORTER DOES NOT RECALL IF THE PATIENT DEVELOPED ANY SYMPTOMS; HOWEVER AT AN UNSPECIFIED TIME ON (B)(6) 2014, THE REPORTER STATED THE PATIENT RECEIVED TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) AT THE EMERGENCY ROOM (ER). IT IS NOT KNOWN WHAT TYPE OF TREATMENT THE PATIENT RECEIVED DURING HIS VISIT TO THE ER. DURING TROUBLESHOOTING, THE CSR WAS UNABLE TO CONFIRM IF THE METER WAS SET IN THE CORRECT UNIT OF MEASURE SETTING. NO REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357976 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R