BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3190165 · Received June 26, 2013

    Report

    Report Number
    3008382007-2013-18535
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 13, 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
    AS
    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) 2013, THE REPORTER CONTACTED LIFESCAN (B)(6), ALLEGING THAT HER ONETOUCH VERIO METER WAS GIVING INACCURATE HIGH CONTROL READINGS. THE PATIENT STATES SHE OBTAINED A CONTROL READING OF ¿8.6MMOL/L¿. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THAT THE CONTROL SOLUTION WAS WITHIN DATE; HOWEVER, THE ALLEGED ISSUE REMAINS UNRESOLVED. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT SUFFER SIGNS OR SYMPTOMS INDICATIVE OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291016 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3351640

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR