BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1860552 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08903
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRALINK METER IS READING ABOVE THE CONTROL SOLUTION RANGE. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. THE INACCURATE CONTROL HIGH ISSUE BEGAN ON (B)(6) 2010. SOMETIME AFTER THE PRODUCT ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SHAKY, COLD, AND CLAMMY. ON (B)(6) 2010, THE PATIENT CLAIMED SHE MANAGED HER DIABETES WITH 3-4 GLUCOSE TABLETS AT 11:30 AM. THERE WERE NO ALLEGATIONS OF MEDICAL TREATMENT DUE TO THE CONTROL SOLUTION ISSUE. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE CUSTOMER CARE ADVOCATE VERIFIED THAT A CONTROL SOLUTION RESULT OF "140 MG/DL" WAS ABOVE THE CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 76 MG/DL, 501 MG/DL, 230 MG/DL AND 300 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3038409

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening