BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1173425 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02364
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER "DOES NOT TURN ON." THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT TESTS HER BLOOD GLUCOSE TWICE A DAY AND MANAGES HER DIABETES WITH PILLS, DIET AND EXERCISE. AT AN UNKNOWN TIME ON THE EVENT DAY, THE PATIENT STATED THAT HER METER WOULD NOT TURN ON AND AS A RESULT THE PATIENT DID NOT MAKE ANY CHANGES IN REGARDS TO HER DIABETES REGIMEN. AT AN UNSPECIFIED TIME AFTER THE REPORTED ISSUE, THE PATIENT REPORTEDLY EXPERIENCED THESE SYMPTOMS: DIZZY, LIGHTHEADED, DRY MOUTH AND URINATING FREQUENTLY (TYPICAL OF HIGH BLOOD GLUCOSE). THE PATIENT STATED THAT SHE CALLED HER HEALTHCARE PROFESSIONAL (HCP) THE SAME DAY (UNKNOWN TIME) AND WAS TOLD THAT SHE WAS GOING TO NEED A BLOOD TEST BECAUSE THE METER STOPPED WORKING. IT WAS NOT SPECIFIED WHEN THE PATIENT WOULD GET THE BLOOD TEST. DURING THIS TIME, THERE WERE NO OTHER TREATMENTS MENTIONED AND BLOOD GLUCOSE TEST WAS NOT PERFORMED ON ANY OTHER DEVICES. DURING TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW OUT OF BOX PRODUCT AND THERE WAS NO METER TRAUMA. THE PATIENT DID NOT REPLACE THE BATTERY PER THE OWNER'S MANUAL AND THE PATIENT DOES NOT HAVE EXTRA BATTERIES TO TEST THE METER WITH. THE METER WOULD NOT POWER ON WHEN THE POWER BUTTON WAS PRESSED OR WHEN THE TEST STRIP WAS INSERTED ALL THE WAY INTO THE TEST STRIP PORT. THE PATIENT'S PRODUCTS HAVE BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED AS MDR REPORTABLE DUE TO THE FOLLOWING CONCLUSIONS: THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT'S REPORTED SYMPTOMS CAN BE ASSOCIATED WITH HYPERGLYCEMIA AND IT REPORTEDLY DEVELOPED AFTER THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2800024

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R