BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2105328 · Received May 27, 2011

    Report

    Report Number
    2939301-2011-04452
    Event Type
    Injury
    Date Received
    May 27, 2011
    Report Date
    May 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 # K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (B)(4) ALLEGING THAT ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING OF "235 MG/DL" COMPARED TO NORMAL READING/FEELING. REPORTEDLY, THE PATIENT TOOK INSULIN BASED ON THE REPORTED READING. SUBSEQUENTLY TWO HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "SWEAT AND HEADACHE." DURING TROUBLESHOOTING, THE PATIENT NOTED THE FOLLOWING: THERE WAS NO CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. THE UNIT OF MEASUREMENT WAS CORRECTLY SET. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPERGLYCEMIC AFTER SHE TOOK INSULIN PER AN ALLEGEDLY INACCURATE HIGH READING OBTAINED ON THE LFS PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening