BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 1951413 · Received January 6, 2011

    Report

    Report Number
    2939301-2011-00216
    Event Type
    Injury
    Date Received
    January 6, 2011
    Report Date
    December 26, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K)# IS K023948. 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), 2010 ALLEGING AN UNSPECIFIED ERROR MESSAGE ON HER ONE TOUCH BASIC METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN IN THE MORNING OF AN UNSPECIFIED DAY IN (B)(6) 2010. DUE THE ALLEGED ISSUE, THE PATIENT CONTINUED TO TAKE HER USUAL DOSAGE OF MEDICATION, HUMALIN 70/30. THE FOLLOWING DAY, THE PATIENT DEVELOPED SYMPTOMS OF FEELING AND SHAKY. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE ALLEGE DISUSE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE UNSPECIFIED ERROR MESSAGE, SHE WAS UNABLE TO TEST AND THE FOLLOWING DAY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening