BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1992283 · Received February 15, 2011

    Report

    Report Number
    2939301-2011-01386
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K062195. 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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRA METER DID NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE OCCURRED 5 YEARS PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED THE SUBJECT METER STOPPED TURNING ON AFTER THE METER WAS EXPOSED TO WATER. AT THE TIME THE ALLEGED POWER ISSUE STARTED, THE PATIENT STATED SHE WAS MANAGING HER DIABETES WITH INSULIN (BASED ON A SLIDING SCALE ON METER RESULTS). AS A RESULT OF NOT BEING ABLE TO TEST, THE PATIENT CLAIMED SHE GUESSED HOW MUCH INSULIN TO ADMINISTER BASED ON HER "FEELINGS" AT THE TIME. A COUPLE OF DAYS AFTER THE ALLEGED POWER ISSUE STARTED, THE PATIENT REPORTED SHE DEVELOPED SYMPTOMS OF FEELING SWEATY, DIZZY, CONFUSED AND HEART PALPITATIONS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM. THE PATIENT STATED HER BLOOD GLUCOSE WAS APPROXIMATELY "2.4 MMOL/L" WHEN TESTED WITH THE ER/HOSPITAL'S METER AND TREATED WITH "GLUCOSE" AND FOOD. AT THE TIME OF TROUBLESHOOTING, THE PATIENT INFORMED THE CSR SHE NO LONGER HAD THE SUBJECT METER; THEREFORE, A SERIAL NUMBER WAS NOT PROVIDED. 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 POWER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R