BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3000926 · Received March 13, 2013

    Report

    Report Number
    3008382007-2013-04809
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4), 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING. THE ALLEGED ISSUE WAS NOT OBSERVED. THE RETURNED TEST STRIPS WERE ALSO EVALUATED; HOWEVER, THE TEST STRIPS FAILED TESTING. THE TEST STRIP VIAL DESICCANT WAS FOUND TO HAVE TOO MUCH MOISTURE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013,, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AROUND 11PM. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF "152 MG/DL" WITH THE SUBJECT METER PRIOR TO GOING TO BED. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE PATIENT DENIED MAKING CHANGES TO HER USUAL MANAGEMENT ROUTINE. AFTER, THE PATIENT CLAIMS HER HUSBAND WOKE HER UP BECAUSE SHE WAS SWEATING PROFUSELY. THE PATIENT'S BLOOD GLUCOSE WAS NOT TESTED AT THAT TIME. ALTHOUGH THE PATIENT CLAIMS SHE ALSO FELT SLEEPY, THE PATIENT'S HUSBAND ADVISED HER TO EAT SOMETHING. THE PATIENT DENIED DEVELOPING ANY OTHER SYMPTOMS. THE PATIENT ATE PEANUT BUTTER AS TREATMENT AND FELT BETTER SHORTLY AFTER BEFORE GOING BACK TO BED. ON THE FOLLOWING MORNING, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "300 MG/DL" WITH THE SUBJECT METER AND "119 MG/DL" ON HER HUSBAND'S METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT ALLEGED SHE CONTINUED TO COMPARE THE METERS THROUGHOUT THE DAY AND THERE WOULD BE A DIFFERENCE OF "5-10 POINTS" EACH TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. 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
    105403 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3305847

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R