BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3220566 · Received July 11, 2013

    Report

    Report Number
    3008382007-2013-19457
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/20/2013). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 9/10/2013 AND 9/17/2013, RESPECTIVELY, AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/12/2013 AND 9/18/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY 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.

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 - ADDITIONAL INFORMATION - (09/20/2013). THIS SUPPLEMENTAL IS BEING SENT TO CORRECT INFORMATION THAT WAS SUBMITTED PREVIOUSLY. THE FOLLOWING ADDITIONAL INFORMATION WAS OMITTED FROM FOLLOW-UP #1: THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 08/27/2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO ANOTHER BACK UP METER AS WELL AS DOCTOR¿S METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED PRIOR TO THE START OF THE ALLEGED ISSUE THE PATIENT HAD SYMPTOMS OF ¿DIZZINESS, BLURRED VISION AND SHAKING.¿ THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 2:44 PM. THE PATIENT REPORTED OBTAINING READINGS OF ¿277, 205 AND 310 MG/DL¿ ON THE LFS METER. THE PATIENT COMPARED THESE READINGS TO ¿165 AND 159 MG/DL¿ ON A DOCTOR¿S METER AND ¿159, 165, 166 AND 106 MG/DL¿ ON A CONTOUR METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4) WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2013 AT 7 PM, HE HAD AN INCREASED DOSE OF MEDICATION INCLUDING HUMALOG 20 UNITS AND LANTUS 50 UNITS. ALTHOUGH THE PATIENT REPORTED THE SYMPTOMS OCCURRED PRIOR TO THE START OF THE ALLEGED ISSUE, AND THEREFORE THE METER COULD NOT HAVE CAUSED THE ALLEGED INJURY. THE PATIENT REPORTED THERE WAS A DELAY IN TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320599 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3459347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR