BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1040607 · Received May 9, 2008

    Report

    Report Number
    2939301-2008-00703
    Event Type
    Injury
    Date Received
    May 9, 2008
    Report Date
    April 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ON APRIL 16, 2008 AND ALLEGED THAT HER ONE TOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED IN 2008. SHE DID NOT PROVIDE ANY BLOOD GLUCOSE RESULTS OBTAINED ON THE METER OR THE LAB RESULT TO WHICH SHE WAS COMPARING THE ALLEGED HIGH RESULT. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT TOOK HUMALOG 8 UNITS BASED ON THE SLIDING SCALE. SHE ALSO MENTIONED EXPERIENCING LIGHT-HEADEDNESS, SHAKINESS, AND BEING SWEATY AFTER THE ISSUE BEGAN. THE PATIENT RECEIVED ASSISTANCE/ADVICE FROM A HEALTHCARE PROFESSIONAL TO TAKE ORANGE JUICE, GLUCOSE TABLET, AND OBTAIN A NEW MACHINE. THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT WAS UNABLE/UNWILLING TO PROVIDE ANY RESULTS OBTAINED ON THE SUBJECT METER, IF HER TESTING TECHNIQUE WAS CORRECT, AND IF THE PUNCTURE AREA WAS CLEANED PROPERLY. IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). THE PATIENT DID NOT WANT TO PERFORM A CONTROL SOLUTION TEST FOR QUALITY CONTROL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN UNSPECIFIED HIGH RESULT. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening