BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1884364 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09538
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K001109.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 AN ERROR 2 MESSAGE ON THEIR ONE TOUCH ULTRA METER AND THAT THE METER WOULD NOT POWER ON . THE PATIENT MENTIONED THAT THE REPORTED ISSUES BEGAN ON (B)(6) 2010 AT AROUND 7:00AM. DUE TO THE REPORTED ISSUES, THE PATIENT SKIPPED THEIR DOSAGE OR STOPPED THEIR MEDICATION. APPROXIMATELY 2 DAYS LATER, THE PATIENT FELT WEAK AND SHAKY. THE PATIENT THEN SELF-TREATED WITH FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. 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 ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE REPORTED ISSUES WITH THE METER, THEY WERE UNABLE TO TEST AND DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND HAD TO SELF-TREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2880647

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R