BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2051525 · Received April 12, 2011

    Report

    Report Number
    2939301-2011-03046
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER POWERS OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 1PM. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, PER CSR'S NOTES THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). IN RESPONSE TO THE ALLEGED METER ISSUE, THE PATIENT INDICATED SHE ADMINISTERED AN INCREASE DOSE OF LANTUS (4 UNITS) EIGHT HOURS LATER; THE REASON FOR INCREASING HER MEDICATION IS NOT KNOWN AND ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DOES NOT HAVE A SECONDARY METER. ON (B)(6) 2011 AT 4AM, THE PATIENT CLAIMED THAT AS A RESULT OF THE ALLEGED ISSUE, SHE DEVELOPED SYMPTOMS OF SHAKING, BLURRY VISION, AND HAD A SEIZURE. THIRTY MINUTES LATER, THE PATIENT INDICATED SHE OBTAINED A READING OF "27MG/DL" WITH THE EMERGENCY MEDICAL SERVICE'S (EMS) METER AND WAS ADMINISTERED IV FLUIDS AS TREATMENT. IT IS NOT SPECIFIED IF THE PATIENT RECEIVED ADDITIONAL TREATMENT, IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOMS IMPROVED, AND IT IS NOT KNOWN IF THE PATIENT WAS LATER TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERIES DID NOT NEED TO BE REPLACED (PER OWNER'S BOOKLET RECOMMENDATION) AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3080824

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R