BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2233606 · Received September 2, 2011

    Report

    Report Number
    3008382007-2011-00323
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LIFESCAN SALES REPRESENTATIVE CONTACTED LIFESCAN (B)(4) ALLEGING THAT A ONE TOUCH VERIO PRO METER HAD A DAMAGED PACKAGING ISSUE. THE REPRESENTATIVE CLAIMED THE PACKAGING WAS WET. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LIFESCAN SALES REPRESENTATIVE CLAIMED THAT THE METER HAD A DAMAGED/WET PACKAGING ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE LIFESCAN SALES REPRESENTATIVE 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 PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1