BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1222065 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02929
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    June 30, 1905
    Report Date
    October 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. SERIAL NUMBER NOT PROVIDED.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A POWER ISSUE WITH THE ONETOUCH ULTRA METER, THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CORRESPOND WITH THE PATIENT BY TELEPHONE ON OCT 31, 2008 AND CLASSIFIED THE COMPLAINT BASED ON THE FOLLOWING INFO RECEIVED FROM THE CUSTOMER. THE PATIENT TESTS HIS BLOOD GLUCOSE 3 TIMES A DAY. HE MANAGES HIS DIABETES VIA METFORMIN 1000 MG, GLYBURIDE AND ACTOS. THE PATIENT STATED THAT THE REPORTED ISSUE BEGAN 4 OR 5 MONTHS PRIOR TO CONTACTING LFS. DURING THAT TIME, THE PATIENT NOTED THAT THE SUBJECT METER WOULD NOT TURN ON. THE PATIENT REPORTEDLY CONTINUED TAKING HIS USUAL DOSE OF DIABETIC MEDICATIONS FOLLOWING THE REPORTED ISSUE. AT AN UNSPECIFIED TIME, AFTER THE REPORTED ISSUE BEGAN, HE REPORTEDLY FELT "LITTLE SWEATY." THE PATIENT STATED THAT HE DID NOT DO ANYTHING TO RELIEVE HIS SYMPTOMS AND ALSO HE STATED THAT HE WAS NOT SURE WHETHER HIS SYMPTOMS WERE DUE TO HIGH OR LOW BLOOD SUGAR. THE PATIENT REPORTEDLY DID NOT RECEIVE / REQUIRE ANY MEDICAL TREATMENT FOR THE DIABETES. THE PATIENT WAS NOT TESTED ON ANY OTHER METER. THE PATIENT DID NOT HAVE THE SUBJECT METER DURING THE CALL TO TROUBLESHOOT THE ISSUE. THE PATIENT'S PRODUCTS WERE REPLACED. BASED ON THE PROVIDED INFO, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening