BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAVUE METER

    MDR report key: 3040164 · Received April 8, 2013

    Report

    Report Number
    3008382007-2013-07112
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K043197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS FOUND TO HAVE PC BOARD CONTAMINATION AND DIRTY SPC PIN. 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

    FOLLOW-UP: ((B)(6) 2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2013, WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 HEALTHCARE EMPLOYEE/REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH ULTRAVUE METER IS GIVING INACCURATE HIGH RESULTS OF 214 MG/DL COMPARED TO THE LAB RESULT OF "26 MG/DL.¿" THE PATIENT WAS TAKEN TO THE HOSPITAL DUE TO LOSS OF CONSCIOUSNESS. THE PATIENT WAS INITIALLY TESTED WITH THE SUBJECT METER AND OBTAINED THE ALLEGED INACCURATE HIGH READING OF "214 MG/DL." AT THE TIME OF CONCERN, THE PATIENT WAS TESTED ON ANOTHER LFS METER WITH A RESULT OF "24 MG/DL." THE SUBJECT METER WAS USED TO TEST WITH THE PATIENT AGAIN, OBTAINING A BLOOD GLUCOSE READING OF "354 MG/DL." THE PATIENT REPORTEDLY RECOVERED AFTER HE/SHE RECEIVED TREATMENT WITH GLUCOSE TREATMENT. IT WAS NOTED THAT THE PATIENT'S HYPOGLYCEMIA WAS DUE TO SKIPPING LUNCH AFTER HIS/HER INSULIN INJECTION. DURING THE TROUBLESHOOTING SESSION, THE REPORTER INDICATED THAT THE RESULTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE CONTROL SOLUTION RESULTS WERE WITHIN THE ACCEPTABLE CONTROL RANGE. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND WITHIN THE DISCARD DATE. THE TESTING TECHNIQUE WAS CONFIRMED TO BE CORRECT. THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE ISSUE AND BECAUSE THE PATIENT MAY HAVE HAD DELAY IN TREATMENT AFTER THE PATIENT OBTAINED THE ALLEGED INACCURATE HIGH READINGS. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED A SERIOUS INJURY DUE TO THE REPORTED ISSUE SINCE THE PATIENT WAS HYPOGLYCEMIC PRIOR TO THE ONSET OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144039 OT ULTRAVUE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3406021

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R