BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2201219 · Received August 11, 2011

    Report

    Report Number
    2939301-2011-07255
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/29/2011)-DEVICE EVALUATION: ON (B)(6), 2011 A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING THE APPLY SAMPLE MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 7:30AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). ACCORDING TO THE CSR'S DOCUMENTATION, SHORTLY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CONTINUED WITH HER USUAL DOSE OF MEDICATION AND ADMINISTERED 15 UNITS OF NOVOLOG INSULIN. AN HOUR AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF THIRST AND FELT LIKE SHE WAS "DRUNK". ACCORDING TO THE CSR'S DOCUMENTATION, SOMETIME BETWEEN 8:30-9AM, THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING SODA AND 2 STICKS OF HONEY. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. A T THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. 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 A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3151191

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R