BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2880792 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08725
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 13, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIO IQ METER POWERS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH LANTUS INSULIN AND HUMALOG INSULIN. THE PATIENT REPORTEDLY CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. ON THE EVENING (B)(6) 2012, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF NEUROPATHY. ON THE FOLLOWING DAY, THE PATIENT VISITED HER PHYSICIAN'S OFFICE AND WAS PRESCRIBED NEURONTIN PILLS (600 MG 3X DAILY) AS TREATMENT. THE PATIENT REPORTEDLY OBTAINED AN A1C RESULT AROUND '7." NO ADDITIONAL TREATMENT WAS SPECIFIED. THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. 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. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT 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 3311166

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR