BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1652721 · Received April 5, 2010

    Report

    Report Number
    2939301-2010-02469
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    February 21, 2010
    Report Date
    March 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE PATIENT TESTS HER BLOOD GLUCOSE 2-3 TIMES A DAY. SHE TYPICALLY TESTS BEFORE BREAKFAST AND DINNER, AND WHENEVER SHE FEELS SYMPTOMATIC. THE PATIENT TAKES HUMULIN-N INSULIN "R-INSULIN" BASED ON HER METER READINGS. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON (B) (6) 2010. THE PATIENT REPORTED METER READINGS OF "223, 192, 217, 285, 205, AND 206 MG/DL." IT IS NOT KNOWN WHAT DATE(S)/TIMES THE REPORTED RESULTS WERE OBTAINED. ON (B) (6) 2010, THE PATIENT CLAIMED THAT SHE TOOK TOO MUCH INSULIN BASED ON AN UNKNOWN METER READING SHE HAD OBTAINED THAT DAY. THE PATIENT STATED THAT THE PATIENT WAS IN HER WHEELCHAIR AND THEN FELL TO THE FLOOR. WHILE FALLING, SHE REPORTEDLY HIT HER HEAD ON A REFRIGERATOR WHICH "KNOCKED A HOLE" IN HER HEAD. THE PATIENT MENTIONED THAT THE HOLE REQUIRED STAPLES TO "TACK IT UP." THE PATIENT SAID SHE PASSED OUT ON THE FLOOR FOR AN UNKNOWN PERIOD OF TIME AND HAD BLOOD EVERYWHERE. WHEN THE PATIENT REGAINED CONSCIOUSNESS, SHE MANAGED TO CLIMB BACK INTO HER WHEELCHAIR AND CALLED HER NEIGHBORS. THE NEIGHBORS RUSHED HER TO A HOSPITAL WHERE HER BLOOD GLUCOSE WAS TESTED ON AN UNIDENTIFIED HOSPITAL DEVICE. THE HOSPITAL REPORTEDLY OBTAINED A RESULT OF "34 MG/DL." THE PATIENT STATED THAT SHE WAS TREATED WITH AN INJECTION WITH SUGAR AND WATER IN IT. THE PATIENT WAS ALSO GIVEN FOOD AND ORANGE JUICE. WHEN THE PATIENT'S SYMPTOMS WERE RELIEVED, SHE CLAIMED THAT HER DOCTOR TOLD HER THAT SHE WAS TAKING TOO MUCH INSULIN BASED ON HER READINGS. THE PATIENT DID NOT HAVE TEST STRIPS FOR TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WHERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE PASSED OUT AND RECEIVED MEDICAL TREATMENT FOR HYPOGLYCEMIA IN A HOSPITAL AFTER TAKING INSULIN BASED ON A METER READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2975443

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R