BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1051847 · Received May 22, 2008

    Report

    Report Number
    2939301-2008-00887
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET REC'D IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT HIS ONE TOUCH ULTRAMINI METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST LISTENED TO THE RECORDED CALL AND IS CLASSIFYING THE COMPLAINT BASED ON THE AVAILABLE INFO, AS THE PT COULD NOT BE CONTACTED BY PHONE TO OBTAIN THE ADDITIONAL INFO. IT IS UNKNOWN WHEN DID THE REPORTED ISSUE FIRST STARTED. THE PT MENTIONED THAT HE USES THE REPORTED METER AS A BACK-UP METER AND USES ANOTHER METER TO TEST HIS BLOOD SUGAR REGULARLY. IT IS UNKNOWN WHETHER THE PT WAS ABLE TO TEST HIS BLOOD SUGAR REGULARLY PRIOR TO THE ISSUE. HE ALSO REPORTED EXPERIENCING FREQUENT URINATION OF AN UNKNOWN TIMEFRAME. HE WENT TO THE ER ON TWO DAYS EARLIER AT AROUND 8:00 PM. HE REPORTED THAT HE WAS TESTED AT THE ER AND REC'D A BLOOD SUGAR READING OF 459 MG/DL. HE ALSO CLAIMED HE WAS TREATED WITH INSULIN AND IV FLUIDS AT THE ER. THE CUSTOMER SERVICE AGENT (CSA) DISCOVERED THAT THE PT DID NOT REPLACE THE BATTERIES IN THE METER AS REQUIRED. THE CSA ALSO VERIFIED THAT THE PT WAS USING CORRECT TEST STRIPS AND THERE WAS NO TRAUMA TO THE METER. THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT CLAIMED THE REPORTED METER WAS NOT POWERING ON AND THAT HE HAD TO BE TREATED WITH INSULIN AND IV FLUIDS AT THE EMERGENCY ROOM AFTER THE REPORTED ISSUE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R