BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1853150 · Received October 5, 2010

    Report

    Report Number
    2939301-2010-08767
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 24, 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT'S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WAS PROMPTING THE BATTERY ICON SYMBOL. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S RELATIVE REPORTED THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED TIME IN (B)(6) 2010. THE REPORTER CLAIMED THAT THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN) AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE REPORTER STATED THE PATIENT CONTINUED HIS USUAL DIABETES MANAGEMENT ROUTINE. APPROXIMATELY 1 MONTH AFTER THE ISSUE BEGAN, THE REPORTER INDICATED THE PATIENT BECAME SWEATY; A SYMPTOM HE ASSOCIATED WITH A LOW BLOOD GLUCOSE. THE REPORTER DENIED THAT THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE REPORTER INFORMED THE CCA THAT THERE WAS NO MISUSE OF THE PRODUCT. THE CCA CONFIRMED THAT THE PATIENT HAD REPLACED THE SUBJECT METER'S BATTERIES PER THE OWNER'S BOOKLET RECOMMENDATION. THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2978137

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening