BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1802020 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06676
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    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 THE ONETOUCH ULTRA METER HAS AN APPLY SAMPLE ISSUE. ON (B)(6) 2010, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT'S DAUGHTER TO CLARIFY INFORMATION OBTAINED DURING THE INITIAL PHONE CALL. THE PATIENT TESTS HER BLOOD GLUCOSE ONCE PER DAY AND MANAGES HER DIABETES WITH ORAL MEDICATION. ON (B)(6) 2010, THE PATIENT WAS HAVING TROUBLE OBTAINING A BLOOD GLUCOSE READING ON THE SUBJECT METER DUE TO THE ALLEGED PRODUCT ISSUE. FOR ONE WEEK, THE PATIENT REPORTEDLY WAS UNABLE TO TEST HER BLOOD GLUCOSE. THE PATIENT CONTINUED TO TAKE HER DIABETES MEDICATION DESPITE THE PRODUCT ISSUE. 2 DAYS PRIOR TO THE ALLEGED PRODUCT ISSUE, THE PATIENT HAD BEEN OBTAINING ELEVATED BLOOD GLUCOSE READINGS IN THE "300S MG/DL." ON (B)(6) 2010, THE PATIENT COMPLAINED THAT HER FOOT WAS HURTING. HER FOOT WENT FROM RED TO PURPLE WITHIN A COURSE OF 2 DAYS. ON (B)(6) 2010, HER FOOT PAIN BECAME EXCRUCIATING. SHE WAS TAKEN TO THE HOSPITAL BY HER DAUGHTER. UPON ARRIVAL, HER BLOOD GLUCOSE READING "560 MG/DL" ON THE HOSPITAL METER. THE DOCTOR DIAGNOSED HER WITH GANGRENE AND HYPERGLYCEMIA. SHE RECEIVED INSULIN TREATMENT AND SUBSEQUENTLY HAD HER FOOT ALLEGEDLY AMPUTATED. HER HOSPITAL STAY WAS 4 DAYS. AFTER HER RELEASE FROM THE HOSPITAL, THE DOCTOR PROVIDED HER WITH A GLUCOSE METER. THE PATIENT CURRENTLY TESTS HER BLOOD GLUCOSE ONCE PER DAY AND MANAGES HER DIABETES WITH METFORMIN. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE APPLY SAMPLE ISSUE WAS RESOLVED WITH TRAINING. CUSTOMER SERVICE NOTED THAT THE PATIENT WAS NOT USING THE CORRECT TECHNIQUE TO APPLY THE SAMPLE ONTO THE TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR HYPERGLYCEMIA ONE WEEK AFTER THE PATIENT WAS UNABLE TO TEST WITH THE SUBJECT METER DUE TO ALLEGEDLY USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2942813

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R