BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3198271 · Received July 1, 2013

    Report

    Report Number
    3008382007-2013-18728
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS (LOT# 3397323 AND 3354650) INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE ALLEGED INACCURATE READING WAS NOTED ON THE METER MEMORY BUT PA COULD NOT REPRODUCE FAILURE IN TEST. THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 1 PM. THE PATIENT ALLEGED OBTAINING READINGS OF ¿224 MG/DL¿ COMPARED TO ¿160, 260, AND 235 MG/DL¿ ON A DOCTOR¿S TRUE RESULT METER. THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANAGE HER DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 AT 1 PM, SHE TOOK A DECREASED DOSE OF APIDRA INSULIN. THE PATIENT REPORTED 3 HOURS AFTER THE ALLEGED ISSUE BEGAN SHE FELT SYMPTOMS OF ¿HYPOGLYCEMIA, LIGHT HEADED AND LOW BLOOD GLUCOSE¿ AND SHE WAS TAKEN TO THE HOSPITAL. THE PATIENT REPORTED SHE WAS TREATED WITH IV GLUCOSE ON (B)(6) AT 1 PM BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297931 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3397323

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R