BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2880574 · Received December 19, 2012

    Report

    Report Number
    3008382007-2012-08601
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. NO ERROR MESSAGE WAS OBSERVED. THE METER FUNCTION PROPERLY.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 HER ONETOUCH ULTRA2 METER WAS DISPLAYING AN ERROR 5 MESSAGE. 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 10AM). IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF SHAKING TEN MINUTES LATER AND CONSUMED GLUCOSE TABLETS/ GLUCOSE GEL AS SELF-TREATMENT AT THE SAME TIME AFTERWARDS. FIVE MINUTE AFTER ADMINISTERING TREATMENT, THE PATIENT REPORTEDLY TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE AND OBTAINED A READING OF '65MG/DL.' AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THE PATIENT WAS USING THE PROPER TESTING PROCEDURE (PER OWNERS BOOKLET RECOMMENDATION), THE TEST STRIP WAS COMPLETELY DRAWING IN THE PATIENT'S BLOOD SAMPLE, AND THE TEST STRIPS DID NOT PASS THE EXPIRY DATE OR STORED IMPROPERLY. HOWEVER, THE ALLEGED METER ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374838

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R