BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1891409 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09682
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 510(K) # IS K061118. (B)(6) 2010: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN 2 LIFTED HIGH. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT WAS TESTED ON (B)(4) 2010. THE METER WAS FOUND TO HAVE DIRTY SPC PINS. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE ALSO TESTED ON (B)(4) 2010, AND NO FAULTS WERE FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYS AN ERROR 4 MESSAGE. 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 THE MORNING OF (B)(6) 2010. THE PATIENT MANAGES HER DIABETES WITH METFORMIN; DOSAGE OF THE PATIENT'S MEDICATION AND TESTING FREQUENCY ARE NOT KNOWN. AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT INDICATED SHE CONTINUED WITH HER USUAL DIABETES ROUTINE, HOWEVER, IT IS NOT KNOWN IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF HIGH BLOOD GLUCOSE, SPECIFYING SHE FELT DIZZY, WEAK, AND HAD AN UNSPECIFIED VISION ISSUE ON (B)(6) 2010. ON AN UNSPECIFIED DATE/TIME, THE PATIENT WAS ADVISED BY HER PHYSICIAN TO GO TO THE EMERGENCY ROOM (ER). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT WENT TO THE ER ON (B)(6) 2010 (9 AM). PRIOR TO HER ER VISIT, IT IS NOT KNOWN IF THE PATIENT CONTINUED TO EXPERIENCE HER REPORTED SYMPTOMS; IT IS NOT KNOWN IF THE PATIENT ATTEMPTED TO ADMINISTER SELF-TREATMENT; IT IS NOT KNOWN IF HER SYMPTOMS PROGRESSED OR IF HER SYMPTOMS DETERIORATED; AND IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY ADDITIONAL CHANGES TO HER DIET OR ACTIVITY LEVEL. DURING HER ER VISIT, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "457MG/DL" WITH THE ER/HOSPITAL METER AND WAS ADMINISTERED IV FLUIDS AND INSULIN (TYPE AND DOSAGE UNKNOWN) BY A HEALTH CARE PROFESSIONAL (HCP). IT IS NOT KNOWN HOW SOON AFTER THE PATIENT WAS RELEASED FROM THE ER. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE EXPIRY DATE. THE CSR ALSO NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. THE ALLEGED ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, DEVELOPED SYMPTOMS, AND REPORTEDLY WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3028343

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention