BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2042652 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02849
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS 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.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 AN ERROR 2 MESSAGE WHILE PERFORMING A QUALITY CONTROL TEST. 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 ALLEGED THAT THE ISSUE BEGAN ON (B)(6) (YEAR UNCLEAR) AT 8:30AM. THE PATIENT PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, THE PATIENT MANAGES HER DIABETES WITH 500MG OF METFORMIN. THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SLURRED SPEECH, DRY MOUTH AND SHAKING 30 MINUTES LATER. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS PRIOR TO THE ALLEGED ISSUE AND IT IS NOT KNOWN IF THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE AFTER THE REPORTED METER ISSUE BEGAN. ACCORDING TO THE CSR'S DOCUMENTATION, AT AN UNSPECIFIED TIME ON (B)(6) 2011 THE PATIENT RECEIVED FOOD AND/OR DRINK AS TREATMENT BY A HEALTH CARE PROFESSIONAL. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CSR VERIFIED THAT THE PATIENT WAS USING THE CORRECT TEST STRIP; HOWEVER, THE CSR NOTED THAT THE PATIENT WAS NOT USING THE PROPER TESTING TECHNIQUE. THE CSR GUIDED THE PATIENT THROUGH TESTING AND THE ALLEGED ISSUE WAS RESOLVED. 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3034787

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R