BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3011131 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05577
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2013 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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2013 AT 6AM. IT IS NOT KNOWN WHAT BLOOD GLUCOSE READING THE PATIENT OBTAINED WITH THE SUBJECT METER AT THAT TIME. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH A COMBINATION OF MEDICATIONS. IT IS NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE HIGH READING OBTAINED WITH THE SUBJECT METER. THE PATIENT REPORTED THAT HE 'BLACKED OUT' AND BEGAN TO 'SPEAK IN INDIAN TONGUE' AT APPROXIMATELY 10AM THAT MORNING. THE PATIENT ALSO REPORTED THAT BETWEEN 11 AND 12:30PM HE WAS TESTED WITH AN EMS METER AND HIS BLOOD GLUCOSE TESTED AT '37 MG/DL'. THE PATIENT CLAIMED THAT HE TESTED WITH THE SUBJECT METER WITHIN 30 MINUTES OF BEING TESTED WITH THE EMS METER AND THE SUBJECT METER REGISTERED '97 MG/DL.' BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30% AND/OR 30 MG/DL. THE CCA NOTED THAT THE PATIENT WAS UNABLE AND/OR UNWILLING TO CONFIRM IF HE RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE INCORRECT CODE NUMBER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113278 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3382681

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening