BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2152278 · Received July 7, 2011

    Report

    Report Number
    2939301-2011-05565
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRASMART METER, TEST STRIPS AND AN UNKNOWN LANCING DEVICE HAD BEEN DAMAGED AFTER HIS DOG CHEWED THE CARRYING CASE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. ON (B)(6) 2011 THE SMSS MAILED A LETTER REQUESTING THE PATIENT CONTACT MEDICAL SURVEILLANCE. ON (B)(6) 2011, THE PATIENT NOTED HIS METER, TEST STRIPS AND LANCING DEVICE WERE CRACKED AND DAMAGED AFTER HIS DOG CHEWED THE CASE; HE WAS UNABLE TO USE THE METER TO TEST HIS BLOOD GLUCOSE LEVEL. THE PATIENT TOOK NO ACTIONS DUE TO THIS ISSUE. THE PATIENT ALSO EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE HIS BLOOD GLUCOSE LEVEL WAS TESTED TO BE "HIGHER THAN THE METER COULD READ". THE PATIENT WAS TREATED WITH INSULIN. ON (B)(6) 2011, THE PATIENT WENT AGAIN TO THE ER TO HAVE HIS BLOOD GLUCOSE LEVEL TESTED; THE PATIENT WAS UNABLE TO PROVIDE THESE SPECIFIC READINGS. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN AND AN UNSPECIFIED ORAL DIABETES MEDICATION. IT WOULD HAVE BEEN HELPFUL TO DETERMINE WHY THE PATIENT WENT TO THE EMERGENCY ROOM, HIS SPECIFIC RESULTS OBTAINED IN THE ER, HIS SPECIFIC TREATMENT, HIS BLOOD GLUCOSE READINGS PRIOR TO THE INCIDENT AND HIS DIABETES MEDICATION REGIMEN. THERE WAS MISUSE OF THE PRODUCTS IN THAT THE PATIENT ALLOWED THEM TO BE DAMAGED BY A DOG. THE PATIENT ALLEGEDLY SUFFERED SEVERELY ELEVATED BLOOD GLUCOSE READINGS AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    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 49 YR Life Threatening| R