BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2853940 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-07016
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO IQ METER DOES NOT POWER ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE POWER ISSUE BEGAN ON (B)(6) 2012 (TIME NOT SPECIFIED). THE PATIENT'S DIABETES REGIMEN IS NOT KNOWN AND IT IS NOT CLEAR WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF THIRST AND FREQUENT URINATION A FEW HOURS LATER. THE PATIENT INDICATED SHE DID TEST HER BLOOD GLUCOSE WITH ANOTHER DEVICE, HOWEVER, THE PATIENT DOES NOT RECALL THE RESULT. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN AS SELF-TREATMENT AT AN UNCLEAR TIME LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, SHE WAS USING THE CORRECT TEST STRIPS AT THE TIME THE ALLEGED ISSUE OCCURRED, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE SUBJECT METER DID NOT TURN ON WITH THE POWER BUTTON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER 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 3307274

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R