BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2082348 · Received May 9, 2011

    Report

    Report Number
    2939301-2011-03807
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRASMART METER CONTINUED TO PROMPT THE MESSAGE OF "APPLY SAMPLE" EVEN AFTER A BLOOD SAMPLE HAD BEEN APPLIED TO THE TEST STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2011. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH HUMULIN AND HUMALOG INSULIN (BASED ON A SLIDING SCALE). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CONFIRMED HE TOOK A DECREASED DOSE OF HIS INSULIN BECAUSE HE WAS UNABLE TO TEST. AT 1:00AM ON (B)(6) 2011, THE PATIENT CLAIMED HE WOKE UP FEELING SWEATY AND SHAKY. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED THAT HE ADMINISTERED AN UNSPECIFIED AMOUNT OF INSULIN (TYPE UNKNOWN) AND FELT BETTER 30 MINUTES LATER. THE PATIENT DENIED TESTING ON ANY OTHER DEVICE AT THE ONSET OF SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE PATIENT WAS APPLYING THE BLOOD SAMPLE CORRECTLY TO THE STRIP. THE ALLEGED ISSUE REMAINED UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, TOOK A DECREASED DOSE OF INSULIN AS A RESULT OF NOT KNOWING BLOOD GLUCOSE VALUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SERIOUS INJURY 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. 3121863

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R