BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1046492 · Received May 16, 2008

    Report

    Report Number
    2939301-2008-00774
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    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 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/PT CONTACTED LIFESCAN ON APRIL 19, 2008 ALLEGING THAT HER ONE TOUCH ULTRA2 METER WAS GIVING INACCURATE ERRATIC READINGS. ON TWO DAYS EARLIER, THE PT WAS FEELING SWEATY AND SHAKY, AS A RESULT, THE PT TESTED HERSELF ON THE METER AND OBTAINED RESULTS OF 183, 193 AND 145 MG/DL PERFORMED WITH TIME DIFFERENCE OF MORE THAN 20 MINUTES OF EACH OTHER. SHE HAD SOMETHING TO DRINK. ALSO, THE PT CALLED THE FIRE DEPT. THE EMERGENCY SERVICES ARRIVED AND TESTED THE PT ON THEIR EMT METER. THE PT DID NOT RECALL THE EXACT READING, BUT SAID THAT IT WAS LESS THAN 50 MG/DL. THE PT STATED THAT SHE WAS GIVEN SOMETHING TO DRINK, SHE FELT BETTER AFTER 15 MINUTES. THE PT USUALLY TAKES ORAL MEDICATION FOR HER DIABETES MANAGEMENT. THE PT DID NOT RECALL THE NAME OF THE MEDICATION, BUT SHE SAID THAT SHE TAKES 1 PILL IN MORNING AND 1 AT NIGHT. SHE TESTS 3 TIMES A DAY. THE PT ALSO CLAIMED THAT SHE EXPERIENCED THE SAME SYMPTOMS OF HYPOGLYCEMIA ON SIX DAYS PRIOR TO ORIGINAL DATE AND THE NEXT DAY, BUT UPON TESTING ON HER METER, SHE RECEIVED HIGH RESULTS. THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED DURING THE CALL THAT THE PT'S TESTING TECHNIQUE WAS CORRECT. THE RESULTS WERE VERIFIED INTO THE METER'S MEMORY. IT WAS NOTICED THAT THE PT WAS USING INCORRECT TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED AS THE PT HAD BEEN OBTAINING INACCURATELY ELEVATED RESULTS, WHILE EXPERIENCING HYPOGLYCEMIA. WHILE THE PT OBTAINED ELEVATED RESULTS, SHE REQUIRED MEDICAL ATTENTION FOR BLOOD GLUCOSE BELOW 50 MG/DL. THERE IS A POTENTIAL THAT THE PT MAY HAVE DELAYED SELF-TREATMENT BASED ON THE ELEVATED RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R