BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 2382921 · Received December 20, 2011

    Report

    Report Number
    2939301-2011-12508
    Event Type
    Injury
    Date Received
    December 20, 2011
    Report Date
    December 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING A POWER ISSUE WITH HER ONE TOUCH BASIC METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER NOT TURNING ON BEGAN ON AN UNSPECIFIED DAY "ALMOST A MONTH AGO" PRIOR TO CONTACTING LFS. SHE STATED THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF METFORMIN (1000 MG) AND LANTUS (30U) AND DUE TO THE ALLEGED ISSUE SHE CONTINUED TAKING HER USUAL DOSE OF MEDICATION. THE PATIENT CLAIMED "A WEEK" AFTER THE ALLEGED ISSUE STARTED SHE HAD "DRY MOUTH AND WAS URINATING FREQUENTLY". IN RESPONSE TO HER SYMPTOMS, "2 WEEKS" AFTER THE ALLEGED ISSUE STARTED WHILE AT A DOCTOR'S OFFICE VISIT, HER BLOOD GLUCOSE WAS TESTED AND A RESULT OF "24 MG/DL" WAS OBTAINED. SHE ALSO REPORTED THAT HER DOCTOR ADVISED HER TO CONTINUE TAKING HER MEDICATION. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THERE WAS NO INFORMATION OF MISUSE OF THE DEVICE AND THE BATTERIES WERE NOT DUE FOR REPLACEMENT. REPLACEMENT UPGRADED PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE REPORTED ISSUE BEGAN.

    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 62 YR Life Threatening