BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1033905 · Received April 24, 2008

    Report

    Report Number
    2939301-2008-00616
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT. D4: TEST STRIP LOT NUMBER, WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT/LAYPERSON ON APRIL 15 REGARDING HER COMPLAINT ON APRIL 2, 2008. THE PATIENT HAD ALLEGED TO CUSTOMER SERVICE THAT HER ONE TOUCH ULTRA METER WOULD NOT TURN ON DESPITE HAVING REPLACED THE BATTERY THREE WEEKS EARLIER. THE ISSUE COULD NOT BE RESOLVED WITH TROUBLESHOOTING. THE PRODUCTS WERE REPLACED. THE PATIENT, WHOSE REGIMEN IS 500 MG OF METFORMIN TWICE A DAY, REPORTEDLY WAS UNABLE TO TEST DUE TO THE POWER ISSUE AT AN UNRECALLED TIME ON THE MONTH BEFORE. AFTER THE ISSUE, THE PATIENT BECAME SWEATY AND DEVELOPED A HEADACHE. THE PATIENT DID NOT SELF-TREAT. LATER THE SAME DAY, THE PATIENT WAS SEEN BY THE PHYSICIAN DURING A REGULAR SCHEDULED APPOINTMENT. THE PATIENT'S BLOOD PRESSURE AT THE APPOINTMENT "WAS VERY HIGH" AND THE DOCTOR ATTRIBUTED HER SYMPTOMS TO HER ELEVATED BLOOD PRESSURE. THE DOCTOR DID NOT TREAT OR PRESCRIBE BLOOD PRESSURE MEDS: RATHER, SHE RECOMMENDED THAT THE PATIENT CONTINUE TESTING AND RETURN SOON FOR A FOLLOW-UP FOR THE BLOOD PRESSURE ISSUE, AT WHICH TIME BLOOD PRESSURE MEDS MAY BE PRESCRIBED. ALTHOUGH THE PATIENT WAS NOT TREATED, THE PATIENT REPORTED THAT SHE HAD SWEATING THAT OCCURRED AFTER THE POWER ISSUE AND SWEATING CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA. FOR THIS REASON, THE COMPLAINT IS CLASSIFIED AS A SERIOUS INJURY.

    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 40 YR Life Threatening