BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2517249 · Received April 4, 2012

    Report

    Report Number
    2939301-2012-03290
    Event Type
    Injury
    Date Received
    April 4, 2012
    Report Date
    April 4, 2012
    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. LOT NUMBER WAS NOT PROVIDED. THE 510(K) # IS K082513.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER HAD ALLEGED THAT THE PATIENT HAD SOME HYPOGLYCEMIC INCIDENT AND COULD NOT CONFIRM WHETHER IT WAS RELATED TO THE METER. AT THE TIME OF REVIEW OF THE COMPLAINT LIFESCAN CONDUCTED A FOLLOW-UP CALL ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT HAD OBTAINED THE RESULTS OF "272 MG/DL AND 117 MG/DL" WITHIN 20 MINUTES FROM ONE ANOTHER, AT AN UNSPECIFIED TIME LATER THE PATIENT HAD DEVELOPED SYMPTOMS OF SWEATING AND TREMBLING. THE PATIENT HAD NOT ATTEMPTED TO RETEST THEIR BLOOD GLUCOSE DURING THE ONSET OF THE ALLEGED SYMPTOMS. THE PATIENT HAD CONTACTED THEIR PHYSICIAN FOR ASSISTANCE AND WAS ADVISED BY THEIR HEALTH CARE PROFESSIONAL TO SELF TREAT WITH SUGAR. THE PATIENT WAS REPORTED TO HAVE FELT BETTER AFTER SELF-TREATMENT AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. AT THE TIME OF THE CALL IT WAS ALSO CONFIRMED THAT THE SUBJECT TEST STRIPS WERE NOT EXPIRED AND WERE IN GOOD CONDITION. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. BASED ON THE NEW INFORMATION OBTAINED ON (B)(6) 2012, THIS SUBMISSION HAS BEEN RE-CLASSIFIED AS AN ADVERSE EVENT.

    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 89 YR Life Threatening| R