BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1955440 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00323
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 2/28/2011: THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE FAILED TESTING. ON PERFORMANCE TESTING WITH CONTROL SOLUTION THE RESULTS WERE FOUND TO FALL ABOVE THE LABELED RANGE. THEREFORE, THE COMPLAINT IS CONFIRMED. THE RETAIN TEST STRIPS PASSED ALL TESTING. 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

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 02/08/2011 . 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 ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6), 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS EVERY 2 HOURS AND MANAGES HER DIABETES WITH INSULIN PUMP. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT 7:00AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "217, 194, AND 166 MG/DL" WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED SHE CONTINUED TO ADMINISTER HER USUAL 7 UNITS OF HUMALOG INSULIN THAT MORNING. ACCORDING TO THE PATIENT, AN HOUR AFTER THE ALLEGED ISSUE BEGAN, SHE WAS FEELING SHAKY AND SWEATY; WHICH SHE CONFIRMED AS LOW BLOOD SUGAR SYMPTOMS. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CONFIRMED SHE DRANK ½ A CAN OF (B)(6) BETWEEN 8:00AM AND 8:30AM, THEN 20 MINUTES LATER SHE FELT BETTER. THE PATIENT STATED AN HOUR AFTER SHE FELT BETTER, SHE WENT TO SEE HER HEALTH CARE PROVIDER (HCP). AT THE TIME OF THE DOCTOR'S OFFICE VISIT, THE PATIENT STATED SHE WAS TESTED ON ANOTHER METER (ONETOUCH ULTRALINK METER), BUT SHE COULD NOT RECALL THE RESULT OBTAINED. THE PATIENT MENTIONED THEY FOUND OUT THE TEST STRIPS WERE THE ONES THAT WERE NOT WORKING PROPERLY. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE BLOOD GLUCOSE RESULT AND THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2962247

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R