BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1891432 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09684
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 25, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING THAT HIS ONE TOUCH ULTRA METER DOES NOT POWER ON. THE PATIENT MENTIONED THAT HE HAD ACCIDENTLY DROPPED THE METER IN THE WATER ON (B)(6), 2010; HOWEVER, THE METER WAS SITTING IN THE WATER FOR AWHILE BEFORE HE HAD NOTICED IT HAD FALLEN IN THE WATER. DUE TO THE ALLEGED ISSUE, THE PATIENT DECREASED THEIR DOSAGE OF MEDIATION. THE FOLLOWING DAY, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, WEAK, NAUSEA AND SLEEPY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, HE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, THE FOLLOWING DAY.

    Description of Event or Problem · 1

    AFTER A MONTH OF IMPLANTATION, IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED FOR A POSSIBLE POCKET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2994925

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening