BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 4873299 · Received June 27, 2015

    Report

    Report Number
    2939301-2015-26827
    Event Type
    Malfunction
    Date Received
    June 27, 2015
    Report Date
    June 20, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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) 2015 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH VERIO2 METER WAS READING BLOOD AS CONTROL SOLUTION. THE CUSTOMER CARE ADVOCATE (CCA) TRIED TO CONTACT THE PATIENT WITH FOLLOW UP QUESTIONS FROM MEDICAL SURVEILLANCE BUT WAS UNABLE TO REACH THE PATIENT. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2015. THE PATIENT DOES NOT CURRENTLY TAKE ANY MEDICATION TO MANAGE THEIR DIABETES. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿NAUSEA, HEADACHE, VOMITING, FEELING LIKE SOMEONE WAS STABBING THEM WITH A KNIFE AND FELT LIKE CRAP¿. IT IS UNKNOWN WHEN THE PATIENT DEVELOPED THESE SYMPTOMS AND IT WAS UNCLEAR IF THESE SYMPTOMS WERE RELATED TO A SEVERE BLOOD GLUCOSE EXCURSION OR IF THEY WERE DUE TO ANOTHER ILLNESS. THE PATIENT DID NOT REPORT ANY MEDICAL TREATMENT FOR THESE SYMPTOMS. THE PATIENT ALSO REPORTED MULTIPLE INACCURACIES WITH THE SUBJECT METER WHILE USING ANOTHER LOT OF TEST STRIPS. THE CCA WAS UNABLE TO COMPLETE TROUBLESHOOTING AS THE PATIENT WAS UNWELL AND SO THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED SYMPTOMS WERE MORE LIKELY CAUSED BY THE REPORTED INACCURACY USING ANOTHER TEST STRIP LOT; THIS ADVERSE EVENT HAS BEEN REPORTED UNDER ANOTHER REPORT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416906 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3761432

    Patients

    Seq Age Sex Outcome Treatment
    1