BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1993959 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01410
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K021819. 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 (B)(4) ON (B)(6) 2011 ALLEGING THAT HIS ONE TOUCH ULTRASMART METER WOULD NOT POWER ON. THE PATIENT DID NOT HAVE THE METER OR TEST STRIPS WITH HIM DURING HIS CALL TO LFS. THE PATIENT MENTIONED THAT THE METER STOPPED WORKING AROUND (B)(6) 2011. ON (B)(6) 2011, THE PATIENT FELT BAD AND EXPERIENCED BLURRED VISION AND WAS SHIVERING. HE CONTACTED EMS AND WAS TESTED ON THE EMS METER AND OBTAINED A 565 MG/DL. HE WENT TO THE HOSPITAL AND WAS TREATED WITH INSULIN. HE WAS ADMITTED AND WAS RELEASED ON THE (B)(6) WITH A BLOOD GLUCOSE OF 231 MG/DL. HE CLAIMS AFTER HE WAS DISCHARGED, HE CHANGED HIS DIET TO NOT GO OVER 2000 CALORIES. THE ALLEGED ISSUE WITH THE METER WAS NOT RESOLVED SINCE THE PATIENT DID NOT HAVE THE METER OR TEST STRIPS WITH HIM. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO HIS METER NOT POWERING ON, HE WAS UNABLE TO TEST, LATER DEVELOPED SYMPTOMS,HAD TO BE ADMITTED AND TREATED IN THE HOSPITAL FOR A BLOOD GLUCOSE OF 565 MG/DL.

    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 35 YR Hospitalization| L| R