BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1834044 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07892
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) # IS K001109. SERIAL # OF THE METER WAS NOT PROVIDED. 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 HER ONE TOUCH ULTRA METER DID NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON SEPTEMBER 14, 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT SHE WAS IN THE PROCESS OF MOVING AND HAD PUT THE METER IN A BOX. WHEN SHE GOT HER METER OUT, SHE NOTICED THAT THE SIDES OF THE METER WERE SLIGHTLY "CRUSHED" AND WAS UNABLE TO POWER THE METER ON STARTING ON (B)(6) 2010. DUE TO THE METER NOT POWERING ON SHE CONTINUED TO TAKE HER ORAL MEDICATION OF METFORMIN 500 MG TWICE A DAY. SOMETIME ON (B)(6) 2010, AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OFF AND ON OF HEADACHES, FEELING THIRSTY, SWEATY AND FEELING LIGHT HEADED. SHE CLAIMS SYMPTOMS WOULD LAST FOR 45 MINUTES. SHE WAS NOT TESTED ON ANOTHER DEVICE AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT DISCARDED THE METER. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2939568

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening