BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1812473 · Received August 24, 2010

    Report

    Report Number
    2939301-2010-07088
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Report Date
    August 8, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT'S FATHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER READ INACCURATELY HIGH WITH THE CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2010 AT 8AM. ACCORDING TO THE CSR DOCUMENTATION, THE PATIENT EXPERIENCED DIZZINESS APPROXIMATELY 15-20 MINUTES AFTER THE ALLEGED ISSUE BEGAN. THE REPORTER DENIED THAT THE PATIENT TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE. THE PATIENT MANAGES HIS DIABETES WITH AN INSULIN PUMP; HOWEVER, BASED ON THE CSR DOCUMENTATION, THIRTY MINUTES AFTER THE ALLEGED ISSUE BEGAN THE PATIENT TOOK AN EXTRA 5 UNITS OF INSULIN (TYPE UNSPECIFIED). FORTY-FIVE MINUTES FOLLOWING THE ALLEGED ISSUE, THE REPORTER INDICATED THAT THE PATIENT CONSUMED ORANGE JUICE AND SODA. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER. THE CSR ALSO NOTED THAT THE PATIENT FOLLOWED THE CORRECT BLOOD GLUCOSE TESTING PROCEDURE (PER OWNER'S BOOKLET). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED. THERE IS NO EVIDENCE, HOWEVER, THAT THE PATIENT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THE PATIENT'S REPORTED SYMPTOM OF DIZZINESS DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THERE IS ALSO NO EVIDENCE OF A DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2901877

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR