BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1813352 · Received August 24, 2010

    Report

    Report Number
    2939301-2010-07098
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRA METER DOES NOT TURN OFF. THE PATIENT MANAGES HIS DIABETES WITH SELF ADJUSTING INSULIN. THE POWER ISSUE BEGAN 3 DAYS PRIOR TO CONTACTING LFS. THE PATIENT DID NOT TAKE ANY ACTION IN REGARDS TO HIS DIABETES MANAGEMENT BASED ON THE POWER ISSUE. REPORTEDLY A FEW HOURS AFTER THE ONSET OF THE POWER ISSUE, THE PATIENT HAD SYMPTOMS DESCRIBED AS "BLOOD SUGAR LOW." THERE WAS NO ALLEGATION OF MEDICAL INTERVENTION FOR ACUTE COMPLICATION OF DIABETES AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD "BLOOD SUGAR LOW" A FEW HOURS AFTER THE 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. 2997775

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening