BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2378017 · Received December 15, 2011

    Report

    Report Number
    2939301-2011-12339
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    December 7, 2011
    Report Date
    December 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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.THE 510K#: K082513.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/REPORTER IN (B)(6), THE PATIENT'S SON, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VITA METER WOULD NOT POWER ON. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE REPORTER TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HIM BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED TO CUSTOMER SERVICE. ON APPROXIMATELY (B)(6) 2011, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ON (B)(6) 2011 AT 5:00 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF DIZZINESS AND SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT BY DRINKING SUGAR-WATER; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT, THE METER WOULD POWER ON WITH THE POWER BUTTON, BUT WOULD NOT POWER ON UPON TEST STRIP INSERTION. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE PATIENT TOOK HER USUAL MEALS AND MEDICATIONS DURING THE TIME PERIOD SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS, IF THE PATIENT HAD A BACKUP METER, THE PATIENT'S MEDICATION REGIMEN AND HER ACTIVITIES AND MEDICAL CONDITION PRIOR TO THE ONSET OF SYMPTOMS. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER POWER ISSUE, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R