BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2433549 · Received January 31, 2012

    Report

    Report Number
    3008382007-2012-00233
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 510K# IS K110637.

    Description of Event or Problem · 1

    ON (B)(6), 2012 THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HE WAS EXPERIENCING AN "ER2" WARNING ISSUE WITH HIS ONE TOUCH VERIO IQ METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6), 2012, ONE HOUR PRIOR TO CONTACTING LFS. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH PILLS, DIET AND/OR EXERCISE AND DUE TO THE ALLEGED ISSUE HE CONTINUED TAKING HIS USUAL DOSE OF MEDICATION. HE CLAIMED A FEW MINUTES AFTER THE ALLEGED ISSUE STARTED, HE FELT SHAKY AND HOT. IN RESPONSE TO HIS SYMPTOMS, ON (B)(6), 2012 AT 1 PM HE REPORTEDLY SELF TREATED WITH AN ADDITIONAL DOSE OF HIS ORAL MEDICATION (UNABLE TO RECALL THE NAME). THERE WAS ANOTHER DEVICE AVAILABLE AT THE TIME OF THE CONCERN, BUT DID NOT HAVE THE TEST STRIPS FOR IT. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS, PROPER TESTING TECHNIQUE AND THERE WAS NO INFORMATION OF MISUSE OF THE DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE REPORTED 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 3200329

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R