BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 3233231 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20166
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY LOW COMPARED TO A LABORATORY DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 8-10X DAILY AND MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿116 MG/DL¿ WITH THE SUBJECT METER AND ¿159 MG/DL¿ ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS¿S CRITERIA FOR ACCURACY. THE PATIENT DID NOT MAKE CHANGES TO HER USUAL MANAGEMENT ROUTINE. THE PATIENT CONFIRMED THE SUBJECT METER HAD BEEN READING WITHIN HER USUAL RANGE. THE PATIENT DENIED DEVELOPING SYMPTOMS DUE TO THE REPORTED ISSUE. DURING A ROUTINE VISIT AT THE PHYSICIAN¿S OFFICE, THE PATIENT WAS PROVIDED ANOTHER DEVICE TO TEST WITH. NO ADDITIONAL TREATMENT WAS PROVIDED. 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. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT DENIED DEVELOPING SYMPTOMS. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334446 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3325419

    Patients

    Seq Age Sex Outcome Treatment
    1