BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA METER

    MDR report key: 2515642 · Received April 3, 2012

    Report

    Report Number
    2939301-2012-03246
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Report Date
    March 29, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE 510K # K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) CANADA ALLEGING THE ONETOUCH ULTRA WILL NOT POWER ON. REPORTEDLY, THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR TWO WEEKS DUE TO THE POWER ISSUE AND SUBSEQUENTLY DEVELOPED SYMPTOMS DESCRIBED AS "SHAKY, SWEATY, OVERALL NOT FEELING WELL." THE SYMPTOMS ABATE AFTER THE PATIENT DRANK SOME SODA. DURING TROUBLESHOOTING, THERE WAS NO EVIDENCE OF PRODUCT MISUSE. BASED ON THE CUSTOMER CARE ADVOCATE'S EXPERTISE, THE SUBJECT METER NEEDED NEW BATTERY BUT THE PATIENT DID NOT HAVE A REPLACEMENT BATTERY AT THE TIME OF CONCERN TO RESOLVE THE ISSUE. THE SUBJECT PRODUCT IS BEING REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE POWER ISSUE BEGAN.

    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 83 YR Life Threatening| R