BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2499123 · Received March 21, 2012

    Report

    Report Number
    3008382007-2012-01019
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THE 510(K) # IS K110637.

    Description of Event or Problem · 1

    ON (B)(6), 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH VERIO IQ METER WAS DISPLAYING AN "APPLY SAMPLE" MESSAGE AFTER THE SAMPLE WAS APPLIED TO THE TEST STRIP. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN EARLIER THE SAME DAY HE CONTACTED LFS FOR ASSISTANCE AT APPROXIMATELY 8AM. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN AND IS A SELF ADJUSTER, IT IS NOT KNOWN IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. HE CLAIMED THAT APPROXIMATELY 5 HOURS LATER AT 1PM, HE DEVELOPED SYMPTOMS OF "SHAKING AND SWEATING" AND SELF TREATED HIS SYMPTOMS WITH FOOD/DRINK IMMEDIATELY AT 1PM. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THAT THE CORRECT TEST STRIPS WERE BEING USED AND THE PATIENT WAS REPORTEDLY PERFORMING THE TEST CORRECTLY. THE ALLEGED ISSUE WAS RESOLVED WITH A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3205421

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R