BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1832521 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07787
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510K # IS K062195. 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 HIS ONETOUCH ULTRA METER SET TO THE INCORRECT UNIT OF MEASURE SETTING (MMOL/L). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT AN UNSPECIFIED ERROR MESSAGE BEGAN TO APPEAR ON THE SUBJECT METER A FEW WEEKS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN; HOWEVER, DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS, BUT REPORTED THAT HIS PHYSICIAN TREATED HIM WITH 4 ADDITIONAL UNITS OF LANTUS INSULIN DURING A DOCTOR'S OFFICE VISIT ON (B)(6) 2010. THE PATIENT DENIED THAT HIS BLOOD GLUCOSE WAS TESTED WITH ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE ALLEGED ERROR MESSAGE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED WITH INSULIN BY AN HCP AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2866708

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R