BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2270463 · Received September 30, 2011

    Report

    Report Number
    2939301-2011-09697
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    September 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 510 (K) # IS K082513.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (LIFESCAN) (B)(4) ON (B)(6) 2011 ALLEGING THAT HER ONE TOUCH VITA METER WOULD NOT POWER ON. THE PATIENT MENTIONED THAT EVEN AFTER REPLACING THE BATTERY THE ISSUE STILL PERSISTED. THE ALLEGED ISSUE WITH THE METER NOT POWERING ON STARTED ON THE EVENING OF (B)(6) 2011. DUE TO THE ALLEGED ISSUE SHE WAS UNABLE TO TEST AND ON THE NIGHT OF (B)(6) 2011, SHE DEVELOPED SYMPTOMS OF FEELING DIZZY, NAUSEATED AND TIRED. SHE DID NOT TAKE ANY MEDICATION AND SHE CONTACTED EMS AND WAS TAKEN TO THE ER WHERE SHE WAS TESTED ON THE ER'S METER AND OBTAINED A 198 MG/DL . THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION. THIS IS NOT THE FIRST TIME THE ALLEGED ISSUE BEGAN. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE BATTERY DID NOT NEED TO BE REPLACED AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. CUSTOMER SERVICE REPLACED PRODUCTS AND REQUESTED SUBJECT PRODUCT BACK TO LFS FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON SHE DEVELOPED SYMPTOMS AND HAD TO BE TREATED IN THE ER WITH A GLUCAGON INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3165192

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R