BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2241424 · Received September 9, 2011

    Report

    Report Number
    2939301-2011-08753
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. 510 (K) # IS K021819.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING HIGH READINGS ON THEIR ONE TOUCH ULTRASMART METER. THE PATIENT MENTIONED THAT ON THE EVENING OF (B)(6) 2011 AROUND 10:00PM HE OBTAINED A RESULT OF 480 MG/DL ON THE ONE TOUCH ULTRASMART METER AND LESS THAN 30 MINUTES TESTED ON A ONE TOUCH EASY METER AND OBTAINED A RESULT OF 80 MG/DL. HE TOOK 13 UNITS OF NOVORAPID INSULIN BASED ON HIS MEAL AND THE RESULT HE OBTAINED ON THE ULTRASMART METER. HE DID NOT EXHIBIT ANY SYMPTOMS BASED ON THE METER READING. THE FOLLOWING MORNING HE DEVELOPED SYMPTOMS OF FEELING TIRED, WEAK AND SWEATY. HE THEN TESTED AND OBTAINED A RESULT OF 50 MG/DL. IT WAS NOTED THAT THE TEST STRIPS THE PATIENT HAD BEEN USING WAS EXPIRED ((B)(6) 2010). USING EXPIRED TEST STRIPS MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT HAD TAKEN INSULIN BASED ON AN ALLEGED HIGH READING HE OBTAINED ON THE ULTRASMART METER AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2872379

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening