BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2469306 · Received February 27, 2012

    Report

    Report Number
    2939301-2012-02019
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    February 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE 510(K) # IS K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(4) 2012)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS GIVING INACCURATE LOW CONTROL READINGS WHEN USING TWO DIFFERENT VIALS OF TEST STRIPS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2012 (AT 12:43PM). THE PATIENT CLAIMS HE OBTAINED A CONTROL READING OF ''101MG/DL'' AND THE RANGE FOR THE VIAL OF TEST STRIPS (LOT # 3223452) HE WAS USING WAS ''103-137MG/DL.'' ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH AN INSULIN PUMP AND AT THE SAME TIME AFTER THE REPORTED METER ISSUE OCCURRED, THE PATIENT REPORTEDLY TURNED HIS INSULIN PUMP OFF. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AFTER THE ALLEGED ISSUE OCCURRED AND REPORTEDLY TESTED HIS BLOOD GLUCOSE WITH HIS SECONDARY ONETOUCH ULTRAMINI METER (RESULTS AND TIME OF TEST ARE NOT KNOWN). DURING TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION, THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE (PER OWNER'S BOOKLET RECOMMENDATION), AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (MG/DL). HOWEVER, THE ALLEGED METER ISSUE REMAINS UNRESOLVED. 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 DENIED DEVELOPING ANY SYMPTOMS BECAUSE OF THE ALLEGED METER ISSUE. THERE IS NO INDICATION THE PATIENT RECEIVED ANY MEDICAL INTERVENTION/TREATMENT FOR AN ACUTE COMPLICATION FOR DIABETES AFTER THE ALLEGED METER ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3223452

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR