BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1942450 · Received December 30, 2010

    Report

    Report Number
    2939301-2010-11196
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 2/11/2011: 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 02/03/2011. THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING AN UNSPECIFIED ERROR MESSAGE ON HER ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN 3 DAYS PRIOR TO CONTACTING LFS. DUE TO THE ALLEGED ISSUE, SHE HAD SKIPPED HER DIABETES MEDICATION OF DIMICHRON (30 MG) AT NIGHT. AT AN UNSPECIFIED DATE AND TIME AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF SWEATING, HEADACHES AND FEELING SHAKY INSIDE. SHE DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THIS WAS NOT THE FIRST TIME THE PATIENT WAS USING THE PRODUCT. THE CUSTOMER CARE ADVOCATE (CCA) ASSISTED THE PATIENT AND THE ALLEGED ISSUE WAS RESOLVED OVER THE PHONE. PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SINCE SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE, SHE WITHHELD HER NIGHT DOSAGE OF MEDICATION AND AT AN UNSPECIFIED TIME 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. 2991430

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening