BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2810382 · Received October 31, 2012

    Report

    Report Number
    2939301-2012-12530
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 16, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (10/31/2012) DEVICE EVALUATION: THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A ONETOUCH ULTRALINK METER WAS READING INACCURATELY COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT. ON (B)(6) 2012, THE PATIENT ALLEGED SHE FELT WEAK AND DEHYDRATED, AND SHE WAS SEEN BY HER DOCTOR. THE PATIENT REPORTED, SHE WAS SENT TO THE HOSPITAL FOR ANAPHYLACTIC SHOCK AND WAS ON "LIFE SUPPORT FOR 21 HOURS." ON (B)(6) 2012 AT 6PM, THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "397 AND 169MG/DL" WERE OBTAINED ON THE LFS METER COMPARED TO "277 AND 113 MG/DL" ON A HOSPITAL METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT REPORTED IN RESPONSE TO THE HIGH READINGS, SHE WAS GIVEN 25 UNITS OF NOVOLIN INSULIN VIA HER INSULIN PUMP BY A HEALTHCARE PROFESSIONAL (HCP). THE PATIENT REPORTED SHE NORMALLY TESTS 4 TIMES A DAY AND HER TARGET BLOOD GLUCOSE IS "110MG/DL." THE PATIENT CONFIRMED THAT SHE DID NOT BELIEVE HER SYMPTOMS WERE RELATED TO HER DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT'S TESTING PROCESS WAS CORRECT AND SHE WAS USING AN APPROVED SAMPLE SITE AT THE TIME OF TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. ALTHOUGH THE PATIENT WAS TREATED BY A HEALTHCARE PROFESSIONAL, THE PATIENT CONFIRMED SHE WAS HOSPITALIZED FOR A DIAGNOSIS UNRELATED TO DIABETES. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR