BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2134557 · Received June 20, 2011

    Report

    Report Number
    2939301-2011-04973
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    June 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K082513. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING THAT HER ONE TOUCH VITA METER DOES NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN APPROXIMATELY TWO MONTHS AGO. DUE TO THE ALLEGED ISSUE, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE AND DID NOT HAVE ANOTHER WAY OF TESTING. SHE CONTINUED TO TAKE HER ORAL MEDICATION OF GLUCOPHAGE ON A REGULAR BASIS. APPROXIMATELY A MONTH AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION AND FEELING DIZZY. THE PATIENT DID NOT ATTEMPT TO SELF-TREAT AND CONTACTED EMS. HER BLOOD GLUCOSE READING WAS 60 MG/DL ON THEIR METER AND WAS TREATED WITH GLUCOSE TABLETS/ GLUCOSE GEL. SHE FELT BETTER AN HOUR LATER. THE PATIENT'S DIABETES REGIMEN WAS NOT CHANGED DUE TO THE ALLEGED ISSUE. THE PATIENT WAS USING THE CORRECT TEST STRIPS, AND THERE WAS NO MISUSE OF THE PRODUCT. THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH TESTING AND THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE POWER ISSUE SHE UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS AND HAD TO RECEIVE MEDICAL TREATMENT BY EMS FOR A BLOOD GLUCOSE READING OF 60 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3057298

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R