BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2771699 · Received October 4, 2012

    Report

    Report Number
    3008382007-2012-04759
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 9, 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
    FR
    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) (B)(6) ALLEGING AN ISSUE WITH A MISSING AVERAGE ON HER ONETOUCH VERIO IQ METER. THE CUSTOMER CARE ADVOCATE (CCA) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION DURING A FOLLOW UP CALL; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON CCA DOCUMENTATION FROM THE INITIAL CALL. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF SHE MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT DID NOT SPECIFY DEVELOPING SYMPTOMS OR RECEIVING TREATMENT DUE TO THE ALLEGED ISSUE. THE CCA EDUCATED THE PATIENT ABOUT METER AVERAGES; HOWEVER, THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THERE IS NO EVIDENCE THE PATIENT RECEIVED MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MISSING AVERAGE ISSUE REMAINED UNRESOLVED.

    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 39 YR