BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1911119 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10370
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 12, 2010
    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) # IS K082513.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VITA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE CSR WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH METFORMIN TABLETS (3X A DAY) AND TESTS HIS BLOOD GLUCOSE 2-3 TIMES A DAY. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2010. THE PATIENT STATED HE CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATION. ON THE FOLLOWING DAY, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF "FREQUENT URINATION AND MORE THIRST." THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THE PATIENT DID NOT HAVE ANOTHER DEVICE TO TEST HIS BLOOD GLUCOSE. ON (B)(6) 2010, THE PATIENT STATED HE VISITED HIS PHYSICIAN'S OFFICE AND OBTAINED A BLOOD GLUCOSE RESULT OF "85 MG/DL" ON THE PHYSICIAN'S METER. THE PATIENT STATED HE WAS GIVEN ANTIBIOTICS FOR ANOTHER AILMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE METER WOULD TURN ON WHEN PRESSING BUTTONS. THE CSR ADVISED THE PATIENT HE WAS USING THE INCORRECT TEST STRIPS WITH THE SUBJECT METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3038007

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening