BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1890415 · Received November 3, 2010

    Report

    Report Number
    2939301-2010-09665
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER DISPLAYS THE APPLY SAMPLE MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON THE MORNING OF (B)(6), 2010 (TIME NOT SPECIFIED). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, THE REPORTER DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE, AND CONSEQUENTLY THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF SHAKINESS THIRTY MINUTES LATER. THE REPORTER, HOWEVER, DENIED THE PATIENT RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED METER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE AND WAS USING THE CORRECT TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT AFTER INJECTING A DOSE OF EPINEPHRINE AND THEN ANALYZING THE HEART RHYTHM OF A (B)(6) FEMALE PT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE AND THE DEVICE PROMPTED TO CHANGE THE BATTERIES. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER, IT IS UNK IF THIS IS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3042826

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening