BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2781361 · Received October 10, 2012

    Report

    Report Number
    3008382007-2012-04956
    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
    OK, 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 CONTACTED THE LAY USER/PATIENT AS PART OF AN OUTBOUND CALL, FROM THE UNITED STATES. DURING THE OUTBOUND CALL THE PATIENT ALLEGED THAT THEY WERE UNABLE TO GET THEIR ONETOUCH VERIO IQ METER DUE TO AN UNSPECIFIED ISSUE. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THEIR COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT CLAIMED THAT THE SUBJECT METER WAS HAVING AN UNSPECIFIED ISSUE THAT MADE IT SO THE PATIENT COULD NOT GET THE METER TO WORK. 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 65 YR