BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1151414 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-01995
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 26, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D 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

    IN 2008, THE LAY USER /PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS PROMPTING AN UNSPECIFIED ERROR MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PT ON SEPTEMBER 3, 2008 AND OBTAINED THE FOLLOWING INFO. THE PT REPORTED THAT THE ALLEGED ISSUE BEGAN APPROX 3 MOS PRIOR TO CONTACTING LFS, SINCE HE FIRST STARTED USING THE SUBJECT METER. THE PT FURTHER INDICATED THAT THE ERROR MESSAGE WOULD APPEAR INTERMITTENTLY AND WHEN HE WAS UNABLE TO OBTAIN A READING ON THE SUBJECT METER HE WOULD TEST ON HIS ONETOUCH PROFILE METER. APPROX 2 WEEKS PRIOR TO CONTACTING LFS (DATE/TIME UNK), THE PT ATTEMPTED TO TEST HIS BLOOD GLUCOSE SEVERAL TIMES ON THE SUBJECT METER, BUT CONTINUED TO OBTAIN THE UNSPECIFIED ERROR MESSAGE. THE PT CLAIMED HE DID NOT TEST ON HIS ONETOUCH PROFILE METER THAT DAY BECAUSE HIS FINGERS WERE "SORE" , BUT CONFIRMED HE HAD TAKEN HIS USUAL 40 UNITS OF 70/30 INSULIN THAT MORNING. THE SAME EVENING AT 7:00 PM, THE PT REPORTED THAT HIS SPOUSE FOUND HIM IN A "COMA". THE PT'S SPOUSE REPORTEDLY CONTACTED EMERGENCY SVCS AND WHEN THEY TESTED THE PT'S BLOOD GLUCOSE THEY OBTAINED A 'LOW" READING (RESULT UNK) AND TREATED THE PT WITH IV GLUCOSE. THE PT CLAIMED, HE RESPONDED TO THE TREATMENT AND REFUSED TO BE TAKEN TO THE HOSP. THE PT CONFIRMED HE DID NOT HAVE ANY SYMPTOMS PRIOR TO PASSING OUT. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) DISCOVERED THAT THE PT WAS APPLYING HIS BLOOD SAMPLE TO THE TEST STRIP INCORRECTLY. THE ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODS WERE SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO REPORTED ISSUE AND REPORTEDLY WAS TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2831302

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R