BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1906403 · Received November 23, 2010

    Report

    Report Number
    2939301-2010-10264
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K)K061118. 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 INACCURATE ERRATIC READINGS ON THEIR ONE TOUCH MINI METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH THE INACCURACIES HAPPENED APPROXIMATELY ONE WEEK AGO. THE PATIENT HAD OBTAINED THE FOLLOWING READINGS LESS THAN 20 MINUTES FROM ONE ANOTHER: "39, 670, 700 SOMETHING AND 500 SOMETHING". DUE TO THE INACCURATE READING THE PATIENT ATE MORE FOOD/DRINK. APPROXIMATELY A WEEK AFTER THE ALLEGED ISSUE BEGAN THE PATIENT DEVELOPED SYMPTOMS OF SHAKING, NAUSEA, SWEATING AND BLURRED VISION. THE PATIENT DID NOT SELF-TREAT OR SEEK ANY MEDICAL ATTENTION DUE THE ALLEGED ISSUE. WHILE TROUBLESHOOTING IT WAS NOTED, THAT THE METER HAD BEEN MISCODED. WHEN A METER IS MISCODED, IT MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERRATIC READINGS, THEY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3059758

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening