BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1645167 · Received March 24, 2010

    Report

    Report Number
    2939301-2010-01996
    Event Type
    Injury
    Date Received
    March 24, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 AND DISCOVERED THAT THE ONETOUCH ULTRA2 METER WAS SET TO THE INCORRECT CALIBRATION CODE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT TO OBTAIN/CLARIFY INFORMATION. THE PATIENT IS UNSURE WHEN THE ISSUE STARTED BUT SAYS HER READINGS HAVE BEEN INACCURATELY HIGH ONCE SHE DISCOVERED DURING THE TROUBLESHOOTING TELEPHONE CALL THAT THE METER WAS SET TO THE INCORRECT CALIBRATION CODE SHE MENTIONED THAT HER READINGS HAVE BEEN HIGHER THAN USUAL. SHE SAYS SHE WAS MORE CAREFUL ABOUT WHAT SHE EATS DURING THIS TIME SINCE HER READINGS WERE HIGHER THAN NORMAL. FOR EXAMPLE IN THE MORNINGS FROM (B) (6) THROUGH (B) (6) SHE OBTAINED READINGS OF 187, 252, 197, 160, 268, 246, AND 237 MG/DL ON SEPARATE DAYS. ON (B) (6) SHE HAD HER LUNCH AND SAID THAT SHE WENT TO A DIABETES EDUCATION COURSE AT THE LOCAL HOSPITAL AT 2 PM AND STARTED TO FEEL SYMPTOMS OF SHAKINESS AND WEAKNESS. SHE DID NOT KNOW WHAT THE SYMPTOMS WERE OR HOW TO TREAT THEM BUT SAID SHE FELT BETTER AT AROUND 3:30 PM. WHEN ASKED WHETHER THE SYMPTOMS MAY HAVE BEEN PREVENTED IF THE SYMPTOMS WERE READING LOWER SHE SAID THAT THEY PROBABLY COULD HAVE. THE PATIENT DOES NOT TAKE ANY MEDICATIONS FOR DIABETES AND IS ON DIET CONTROL. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE ISSUE WAS RESOLVED BY WALKING THROUGH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THAT THE CALIBRATION CODE NUMBER WAS INCORRECT ON THE METER, WHICH PROBABLY CAUSED THE READINGS TO BE INACCURATELY HIGH, AND SUFFERED DIABETIC SYMPTOMS DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2989611

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R