BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1896976 · Received November 11, 2010

    Report

    Report Number
    2939301-2010-09792
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 6, 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/06/2010. 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.

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K053529. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY, PREVENTING USE OF THE SYSTEM. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING THAT SHE WAS UNABLE TO OBTAIN A READING ON HER ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT ON (B)(6) 2010 AT 4:00AM, SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE; HOWEVER, WAS UNSUCCESSFUL IN OBTAINING A READING. SINCE THE PATIENT WAS UNABLE TO OBTAIN A READING, SHE TOOK HER USUAL DOSAGE OF MEDICATION. AN HOUR LATER AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD BEEN TESTING IN THE METER MEMORY. CUSTOMER CARE ADVOCATE (CCA) ASSISTED THE PATIENT WITH THE PROPER WAY OF TESTING AND THE ISSUE WAS RESOLVED OVER THE PHONE. ALTHOUGH THE ISSUE WAS RESOLVED OVER THE PHONE, THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO TESTING IN THE MEMORY MODE AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3029463

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening