BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2880785 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08726
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 6-7X DAILY. THE ALLEGED ISSUE BEGAN ABOUT 1-2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF "174 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH PRANDIN PILLS (1 MG/ 2-3X DAILY). BASED ON THE ALLEGED RESULT, THE PATIENT ADMINISTERED HER USUAL DOSE OF MEDICATIONS. ABOUT 30 MINUTES AFTER, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKING, FATIGUE, "IRREGULAR HEART RATE", SWEATING AND IMPAIRED SPEECH WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT ATE CHOCOLATE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION FOR QUALITY CONTROL TESTING. 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 ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3306969

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R