BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1317656 · Received February 18, 2009

    Report

    Report Number
    2939301-2009-01071
    Event Type
    Injury
    Date Received
    February 18, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 3, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR PAST READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PATIENT. ON THE MORNING OF THE SAME DAY, THE PATIENT REPORTED OBTAINING ALLEGED HIGH BLOOD GLUCOSE READINGS OF "220, 194, AND 183 MG/DL" WITH THE SUBJECT METER. IT IS UNKNOWN HOW MUCH TIME ELAPSED BETWEEN THE READINGS. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT TOOK HIS USUAL DOSE OF ORAL MEDICATION (5/500 MG OF GLYBURIDE/METFORMIN, ACTOS, AND JANUVIA). WITHIN MINUTES OF OBTAINING THE ALLEGED HIGH READINGS (TIME UNKNOWN), THE PATIENT STATED THAT HE DEVELOPED THE SYMPTOM OF SWEATING. IT IS UNCLEAR IF THE PATIENT'S SYMPTOM WAS SUGGESTIVE OF HIGH OR LOW BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING TREATMENT AS A RESULT OF THE ALLEGED HIGH READINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED A SYMPTOM SUGGESTIVE OF EITHER HYPOGLYCEMIA OF HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2854424

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening