BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1912038 · Received December 1, 2010

    Report

    Report Number
    2939301-2010-10398
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109. 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 (03/11/11)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE LCD FLAT CABLE WAS PEELED OFF. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING MISSING SEGMENTS ON HIS ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THE REPORTED ISSUE BEGAN SOMETIME 2-3 WEEKS AGO IN THE MORNING. THE PATIENT MENTIONED THAT HE SOON AFTER ATTEMPTING TO INTERPRET THE READING ON HIS METER, HE DEVELOPED SYMPTOMS OF SWEATING AND HAD TO LAY DOWN. HE THEN SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. HE WAS NOT TESTED ON ANOTHER DEVICE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE MISSING SEGMENTS ON HIS METER, HE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R