BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1873317 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09175
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 5, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 510K #K021819.

    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 ULTRASMART METER DOES NOT TURN ON. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE POWER ISSUE BEGAN ON (B)(6) 2010 AT 6 AM. AS A RESULT OF THE POWER ISSUE, THE PATIENT MANAGED HIS DIABETES BY TAKING LESS FOOD AND/OR DRINK AT THE TIME OF CONCERN. 2 HOURS LATER, THE PATIENT CLAIMED THAT HE WAS SWEATING AND EVENTUALLY LOST CONSCIOUSNESS. THE PARAMEDICS ARRIVED AROUND THE SAME TIME AND TREATED THE PATIENT WITH IV GLUCOSE FOR A BLOOD GLUCOSE READING OF "28 MG/DL." ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED SINCE THE PATIENT DID NOT HAVE A REPLACEMENT BATTERY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DECREASED HIS FOOD INTAKE AS A RESULT OF THE POWER ISSUE, PASSED OUT, AND RECEIVED MEDICAL INTERVENTION FOR HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R