BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2871225 · Received December 12, 2012

    Report

    Report Number
    3008382007-2012-07937
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PA FOUND THE METER TO HAVE NO SCRATCHES, HOWEVER, THE OUTLOOK OF THE CASING APPEARS TO BE DIRTY. PA DOWNLOADED DATA AND DID NOT HAVE ANY GLUCOSE VALUES AND THE ERROR LOG FILE WAS CLEAN.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON 1(B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HE HAD RECEIVED A REPLACEMENT METER WHICH LOOKED LIKE IT HAD BEEN PREVIOUSLY USED. THE REPORTER STATED THE METER HAD SCRATCHES AND FINGERPRINTS ON THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    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 3326384

    Patients

    Seq Age Sex Outcome Treatment
    1