BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1100884 · Received August 6, 2008

    Report

    Report Number
    2939301-2008-01716
    Event Type
    Injury
    Date Received
    August 6, 2008
    Report Date
    August 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    ON AUGUST 1, 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONETOUCH ULTRA METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS ABLE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT CLAIMED THAT THE METER WOULD NOT POWER ON SINCE 2-3 MONTHS PRIOR TO CONTACTING LFS. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY INCREASED 4-6 UNITS OF APIDRA TO MANAGE HER DIABETES BECAUSE SHE DID NOT WANT TO GO "LOW". THE PATIENT NORMALLY TESTS HER BLOOD GLUCOSE AT LEAST FOUR TIMES PER DAY AND MANAGES HER DIABETES WITH APIDRA TAKEN ON A SLIDING SCALE. SOMETIME AFTER THE REPORTED METER ISSUE AND THE INCREASE IN INSULIN INTAKE, THE PATIENT REPORTEDLY FELT "DIZZY AND FAINT". THE REPORTER STATES THAT A FAMILY MEMBER TOOK THE PATIENT TO THE EMERGENCY ROOM (ER) AND SHE WAS REPORTEDLY GIVEN 20 UNITS OF INSULIN (UNKNOWN TYPE) WHILE AT THE HOSPITAL. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL FOR ONE DAY AND IT WAS UNKNOWN WHAT KIND OF READING THE PATIENT OBTAINED ON THE ER'S METER BUT THE REPORTER RECALLED THAT IT WAS "HIGH". DURING THIS TIME, THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE AND REPORTEDLY TREATED HERSELF BASED ON HER FEELINGS. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE FOLLOWING WITH THE REPORTER: THE CORRECT TEST STRIPS WERE USED AND BATTERIES WERE INSTALLED CORRECTLY. THERE WAS NO METER TRAUMA AND THIS WAS NOT A NEW OUT OF BOX PRODUCT. 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 ARE BEING REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT WAS REPORTEDLY TREATED AT THE ER FOR POSSIBLE HYPOGLYCEMIA AFTER THE ALLEGED METER 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 2761586

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R