BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2780198 · Received October 10, 2012

    Report

    Report Number
    3008382007-2012-04911
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS NOT REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012 A LIFESCAN (LFS) CUSTOMER CARE ADVOCATE (CCA) CONTACTED THE LAY USER/PATIENT FROM THE UNITED STATES AS PART OF AN OUTBOUND PROGRAM. AT THAT TIME THE PATIENT ALLEGED THAT SHE WAS HAVING DIFFICULTY GOING INTO HER ONETOUCH VERIO IQ METER MEMORY TO SEE THE HIGH AND LOW. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. DURING TROUBLESHOOTING THE PATIENT MENTIONED THAT SHE HAD JUST WOKEN UP AND SO THE CCA WAS UNABLE TO COMPLETE TROUBLESHOOTING. THE ALLEGED ISSUE WAS NOT RESOLVED DURING THE CALL. BASED ON THE INFORMATION PROVIDED, THEIR COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT CLAIMED THAT SHE WAS HAVING DIFFICULTY GOING INTO THE SUBJECT METER'S MEMORY TO SEE THE HIGH AND LOW. THERE IS NO EVIDENCE THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR