BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2268822 · Received September 29, 2011

    Report

    Report Number
    2939301-2011-09649
    Event Type
    Injury
    Date Received
    September 29, 2011
    Date of Event
    September 17, 2011
    Report Date
    September 20, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    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 K072543.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CAPACITOR FAILURE AT C20. AFTER C20 WAS CHANGED, THE METER WORKED PROPERLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING A BATTERY INDICATOR WARNING EVEN AFTER HAVING REPLACED THE BATTERIES THREE TIMES ON HER ONE TOUCH SELECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME OF THE NIGHT OF (B)(6) 2011. SHE STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER) AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. THE PATIENT CLAIMED THAT 15 MINUTES AFTER THE ALLEGED ISSUE BEGAN, SHE FELT "SHAKY AND SWEATY". SHE DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT IN RESPONSE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE BATTERIES HAD BEEN REPLACED RECENTLY AND THERE WAS NO INFORMATION OF MISUSE. REPLACEMENT 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 HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3131130

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening