BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1913152 · Received December 2, 2010

    Report

    Report Number
    2939301-2010-10452
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DISPLAYED AN UNKNOWN MESSAGE. THE CUSTOMER SERVICE REPRESENTATIVE (CSR) NOTED THE PATIENT IS PARTIALLY BLIND. THE PATIENT STATED SHE SAW LETTERS ON THE SUBJECT METER, HOWEVER, COULD NOT TELL WHAT THE MESSAGE WAS INDICATING DUE TO HER VISION PROBLEM. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT RECALL THE DATE/TIME WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); PATIENT'S TESTING FREQUENCY IS NOT KNOWN. IN RESPONSE TO THE ALLEGED METER ISSUE, THE PATIENT INDICATED THAT ON (B)(6) 2010 (AT 8AM) SHE DECREASED HER LANTUS INSULIN AND ADMINISTERED 30 UNITS; PATIENT'S USUAL DOSAGE IS NOT SPECIFIED. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF "TOO MUCH WARMTH AND THIRST" (DATE/TIME NOT KNOWN). THE PATIENT DENIED SHE RECEIVED TREATMENT AFTER THE ALLEGED ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3046864

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening