BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1896773 · Received November 10, 2010

    Report

    Report Number
    2939301-2010-09785
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 25, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K053529. 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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 2 MESSAGE. 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) 2010 AT 6AM. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED (TIME NOT SPECIFIED), THE PATIENT EXPERIENCED A SYMPTOM OF SHAKING. THE PATIENT DENIED SHE RECEIVED MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE REPORTED ISSUE. IT IS NOT KNOWN HOW LONG THE PATIENT'S SYMPTOM LASTED, IT IS NOT SPECIFIED IF THE PATIENT ASSOCIATED THE SYMPTOM WITH HIGH OR LOW BLOOD GLUCOSE, AND IT IS ALSO NOT SPECIFIED IF THE PATIENT TESTED WITH ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING PROPER TESTING TECHNIQUE AND THE CORRECT TEST STRIPS; HOWEVER, THE CSR NOTED THE PATIENT DID NOT HAVE HER TEST STRIPS AVAILABLE AT THE TIME OF THE CALL. THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACKAGING WITH CHANNEL SEAL WAS FOUND TO HAVE INADEQUATE COMPONENT HOLDING, THIS WAS DISCOVERED DURING THE AFFILIATE'S LABELING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3011992

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening