BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1873183 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09158
    Event Type
    Injury
    Date Received
    October 18, 2010
    Report Date
    October 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 #K053529.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON OCTOBER 8, 2010, 2010 ALLEGING THAT THE ONETOUCH® ULTRA2 METER HAS A POWER ISSUE (METER POWERS OFF DURING USE). THE SUBJECT METER POWERS OFF DURING THE COUNTING DOWN AND BEFORE A BLOOD GLUCOSE RESULT COULD BE PROVIDED. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE POWER ISSUE BEGAN 3-4 DAYS PRIOR TO CONTACTING LFS. ON THE DAY OF CONCERN, THE PATIENT CLAIMED THAT HE COULD NOT OBTAIN HIS BLOOD GLUCOSE READING TO MANAGE HIS DIABETES ACCORDINGLY. ON THAT SAME DAY AFTER THE ONSET OF THE POWER ISSUE, THE PATIENT REPORTEDLY HAD HYPOGLYCEMIC SYMPTOMS OF SEIZURE AND LOSS OF CONSCIOUS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE COULD NOT BE RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3032299

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening