BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2807735 · Received October 29, 2012

    Report

    Report Number
    2939301-2012-12436
    Event Type
    Injury
    Date Received
    October 29, 2012
    Report Date
    October 9, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4)2012) DEVICE EVALUATION: THE SUBJECT METER WAS 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. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4):THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND ON (B)(4) 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATE RESULTS WHEN COMPARED TO THE SAME METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED 30 DAYS PRIOR TO CONTACTING LFS, HE OBTAINED READINGS OF "173, 196, 282, 325, 298, 382 MG/DL" ON THE LFS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=20MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED USING APIDRA INSULIN PUMP THERAPY TO MANAGE HIS DIABETES. THE PATIENT REPORTED IN RESPONSE TO THE ALLEGED ISSUE, HE DECREASED HIS USUAL BOLUS OF MEDICATION, VARYING AMOUNTS ON A "CASE BY CASE BASIS." ON AN UNKNOWN DATE AND TIME IN PROXIMITY TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS OF "SWEATY, SHAKY, NERVOUS, HUNGRY AND WEAK." THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL. THE PATIENT'S TESTING PROCESS WAS FOUND TO BE CORRECT. THE PATIENT'S TEST STRIPS AND TEST STRIP VIAL WERE FOUND TO BE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE SUBJECT METER WAS 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. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMED DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3332626

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening