BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3100886 · Received May 8, 2013

    Report

    Report Number
    3008382007-2013-10608
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THE ONETOUCH VERIO IQ METER "CANNOT PICK UP HER LOW BLOOD GLUCOSE READINGS"; HOWEVER, THE SPECIFIC ISSUE WITH THE SUBJECT METER WAS UNKNOWN. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO REACH THE PATIENT FOR FOLLOW UP QUESTIONS TO OBTAIN ADDITIONAL INFORMATION. DUE TO THE REPORTED ISSUE, THE PATIENT REPORTEDLY VISITED HER PHYSICIAN'S OFFICE TO PERFORM BLOOD GLUCOSE TESTING. RESULTS OBTAINED WITH THE PHYSICIAN'S METER WERE NOT PROVIDED. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF CHANGES WERE MADE TO HER USUAL MANAGEMENT ROUTINE. THE PATIENT DID NOT SPECIFY DEVELOPING SYMPTOMS OR RECEIVING MEDICAL TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE "UNKNOWN" ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201541 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1