BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 2024347 · Received March 18, 2011

    Report

    Report Number
    2939301-2011-02366
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    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

    (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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. 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 (TIME NOT SPECIFIED). THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "230MG/DL" WITH THE SUBJECT METER. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY ADMINISTERED AN INCREASE DOSE OF NOVOLOG (6 UNITS) AND NOVOLIN (60 UNITS) AT AN UNSPECIFIED TIME LATER AND SUBSEQUENTLY, DEVELOPED SYMPTOMS OF SHAKING AND FELT COLD ONE HOUR AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION FOLLOWING THE REPORTED INACCURATE HIGH READING. DURING TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND ALSO NOTED THAT THE PATIENT PERFORMED A QUALITY CONTROL TEST THAT PASSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3067762

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening