BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2222098 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07982
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN UNRECALLED ERROR MESSAGE WHEN TRYING TO TEST HIS BLOOD GLUCOSE ON HIS ONE TOUCH ULTRA METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN 6 DAYS PRIOR TO CONTACTING LFS. HE STATED THAT HE MANAGES HIS DIABETES WITH METFORMIN, AND NOVOLOG INSULIN AND DUE TO THE ALLEGED ISSUE CONTINUED HIS USUAL DOSE OF MEDICATION. THE PATIENT CLAIMED 4 DAYS PRIOR TO CONTACTING LFS, AT AN UNSPECIFIED TIME HE FELT NAUSEATED, SHAKY AND HAD A HARD TIME SEEING. HE ALSO REPORTED THAT 2 DAYS PRIOR TO CONTACTING LFS, AT AN UNSPECIFIED TIME, HE RECEIVED A GLUCOSE RESULT OF "619 MG/DL" FROM AN EMERGENCY MEDICAL SERVICE (EMS) METER. THE EMS HEALTH CARE PROFESSIONAL REPORTEDLY ADMINISTERED TREATMENT BY GIVING 80U OF "FAST ACTING" INSULIN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THERE WAS NO INFORMATION OF MISUSE OF THE METER AND THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3079497

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R