BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 2044575 · Received April 7, 2011

    Report

    Report Number
    2939301-2011-02909
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/11/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) 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 LOW/DEAD BATTERY. A SECONDARY ISSUE WAS ALSO NOTED, THE METER¿S OPTIC WAS FOUND CRACKED. 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 LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH BASIC METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED APPROXIMATELY 1 MONTH PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE MSS THAT SHE MANAGES HER DIABETES BY TAKING AN ORAL MEDICATION AND A SET DOSE OF 75/25 INSULIN IN THE MORNING AND EVENING. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. ON THE AFTERNOON OF (B)(6) 2011, THE PATIENT REPORTED THAT SHE SUDDENLY BECAME VERY HOT AND BEGAN TO SWEAT PROFUSELY. THE PATIENT STATED SHE ASSOCIATED THE SYMPTOMS WITH A HIGH GLUCOSE AND SELF-ADMINISTERED 20 UNITS OF 75/25. SOMETIME AFTER THE SELF-TREATMENT THE PATIENT REPORTED SHE BECAME INCOHERENT AND HER SISTER CONTACTED EMERGENCY SERVICES. WHEN EMERGENCY SERVICES ARRIVED, THE PATIENT STATED THEY TESTED HER BLOOD GLUCOSE AND OBTAINED A LOW RESULT (RESULT NOT KNOWN) AND SHE WAS TREATED WITH IV GLUCOSE. THE PATIENT CONFIRMED SHE FELT BETTER AFTER THE TREATMENT AND DENIED BEING TAKEN TO THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE PATIENT HAD NOT REPLACED THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER'S BOOKLET. 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 WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER 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 63 YR Life Threatening| R