BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 2025501 · Received March 21, 2011

    Report

    Report Number
    2939301-2011-02395
    Event Type
    Injury
    Date Received
    March 21, 2011
    Report Date
    March 12, 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) # IS 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 ON (B)(6) 2011 ALLEGING INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH VITA METER. THE PATIENT HAD OBTAINED THE FOLLOWING RESULTS LESS THAN 20 MINUTES FROM ONE ANOTHER: 479 MG/DL, 201 MG/DL AND 128 MG/DL. THE PATIENT MENTIONED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGE DISUSE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY. THERE IS NO INFORMATION ON WHETHER THE PATIENT RECEIVED ANY MEDICAL TREATMENT OR SELF-TREATED DUE TO THE ALLEGED ISSUE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DIDN'T HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ALLEGED ERRATIC READINGS, HE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3044707

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening