BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3072095 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08591
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THE TEST STRIP PORT WAS BLOCKED. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA). PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED HAVING SYMPTOMS OF "TREMBLING AND SWEATING." THE PATIENT REPORTED IMMEDIATELY AFTERWARDS, THE PATIENT TESTED ON THE LFS METER AND THE ALLEGED ISSUE OCCURED ON (B)(6) 2013 AT 11 AM. THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT REPORTED BEING SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE THE METER COULD NOT HAVE CAUSED THE INJURY. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING WITH THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175064 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR