BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2920327 · Received January 17, 2013

    Report

    Report Number
    3008382007-2013-01057
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    January 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 LAY USER/PATIENT'S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT AND/OR REPORTER BY PHONE. THE PATIENT REPORTED THAT ON (B)(6) 2012 AT 8:30AM, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF "248 MG/DL" WITH THE SUBJECT METER AND "225 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. THE REPORTER INFORMED THE PATIENT MANAGES HER DIABETES WITH INSULIN; HOWEVER, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK REGARDING HER DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED HIGH READING. THE PATIENT'S RELATIVE REPORTED THAT AT 8:45AM THE PATIENT WAS TREATED WITH IV GLUCOSE BY EMS. THE CCA WAS UNABLE TO CONFIRM IF THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A LOW BLOOD GLUCOSE. IT IS ALSO NOT KNOWN IF THE ONSET OF SYMPTOMS OCCURRED BEFORE OR AFTER OBTAINING THE ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY WAS TREATED FOR SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING THE ALLEGED INACCURATE HIGH READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26786 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R