BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3010353 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05566
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIPS WERE EVALUATED AND BOTH PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS ALSO PASSED TESTING. 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

    THE SUBJECT PRODUCT(S) HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAVE NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER WAS NOT POWERING ON. ADDITIONALLY, SHE CLAIMED THE METER DISPLAYED AN "APPLY SAMPLE" MESSAGE AFTER BLOOD WAS ALREADY APPLIED. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT OR REPORTER FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE REPORTER CLAIMED THE ALLEGED ISSUES BEGAN ON (B)(6) 2012. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH SELF ADJUSTING INSULIN (UNKNOWN TYPE). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUES. IT WAS NOTED THAT HE INCREASED HIS FOOD/DRINK IN (B)(6). THE REPORTER CLAIMED THAT SOMETIME AT THE END OF (B)(6) HE DEVELOPED SYMPTOMS OF "DIZZINESS, SWEATING, SHAKING AND NAUSEA." IT WOULD HAVE BEEN HELPFUL TO KNOW WHICH ISSUE THE PATIENT WAS HAVING WITH THE METER AT THE TIME OF HIS SYMPTOMS. HE REPORTEDLY SELF TREATED HIS SYMPTOMS IMMEDIATELY WITH GLUCOSE TABLETS/GLUCOSE GEL. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER POWERED ON WITH THE POWER BUTTON, AND WITH THE TEST STRIP. THE APPLY SAMPLE ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING BECAUSE THE PATIENT DID NOT HAVE ANY TEST STRIPS AVAILABLE FOR A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUES AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114370 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3261794

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R