BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1980439 · Received February 7, 2011

    Report

    Report Number
    2939301-2011-01152
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Report Date
    January 11, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) 2011-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY LOW COMPARED TO ANOTHER METER. 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) 2010 AT APPROXIMATELY 10:30AM. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "67MG/DL" WITH THE SUBJECT METER AND "367MG/DL" ON ANOTHER ONETOUCH ULTRALINK METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, AT THE SAME TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT INDICATED SHE CONSUMED MORE FOOD/DRINK. THE PATIENT DENIED SHE DEVELOPED ANY SYMPTOMS AFTER THE REPORTED INACCURATE LOW READING OCCURRED. ACCORDING TO THE CSR'S DOCUMENTATION, FIFTEEN MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "190MG/DL" WITH THE EMERGENCY MEDICAL SERVICES' (EMS) METER AND WAS ADMINISTERED IV FLUIDS BY THE HEALTH CARE PROFESSIONAL (HCP) AT APPROXIMATELY 11AM. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT ADMINISTER INAPPROPRIATE SELF-TREATMENT BASED ON THE BLOOD GLUCOSE METER RESULT. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVED ADDITIONAL MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3061926

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR