BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2080741 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03758
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7:00AM. THE PATIENT CLAIMED SHE IS ON INSULIN TO MANAGE HER DIABETES. ON THE ONSET OF THE ALLEGED ISSUE, THE PATIENT INDICATED SHE SKIPPED OR STOPPED HER DOSE OF MEDICATION. AT AN UNKNOWN TIME, THE PATIENT REPORTED FEELING DIZZY, WEAK, AND DEVELOPED A HEADACHE BEFORE THE ALLEGED ISSUE BEGAN. BY 1:00PM THAT DAY, THE PATIENT INDICATED SHE WENT TO SEE HER HEALTH CARE PROVIDER (HCP) FOR ASSISTANCE. AT THE TIME OF THE DOCTOR'S OFFICE VISIT, THE PATIENT STATED SHE OBTAINED A "400 MG/DL" READING AND WAS ADMINISTERED 8 UNITS OF HUMALOG INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE USED, THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NOT MISUSED, AND THE METER DID NOT REQUIRE NEW BATTERY REPLACEMENT. THE ALLEGED POWER ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY RECEIVED MEDICAL INTERVENTION FROM AN HCP AFTER THE ALLEGED 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. 3085229

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R