BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1883625 · Received October 26, 2010

    Report

    Report Number
    2939301-2010-09481
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K073231. 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

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH ULTRALINK METER. THE PATIENT MENTIONED THAT ON (B)(6) 2010 THEY OBTAINED A RESULT OF 481 MG/DL. APPROXIMATELY 3 HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY AND FELT WEAK. SHE ATE FOOD/DRINK AND CONTACTED THEIR PHYSICIAN FOR ADVICE AND WAS ADVISED TO CONTACT LFS. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. WHILE TROUBLESHOOTING IT WAS NOTED THAT THE PATIENT HAD BEEN USING EXPIRED TEST STRIPS. USING EXPIRED TEST STRIPS MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT THEY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER OBTAINING AN ELEVATED READING ON THEIR LFS METER AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2851220

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R