BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2191747 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06832
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 (TIME NOT SPECIFIED). THE PATIENT'S TESTING FREQUENCY IS NOT SPECIFIED AND THE PATIENT'S DIABETES MANAGEMENT IS UNCLEAR. FOLLOWING THE REPORTED METER ISSUE, THE PATIENT INDICATED HE CONTINUED WITH HIS USUAL DIABETES ROUTINE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS RESULT OF THE ALLEGED ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, ON (B)(6) 2011 (TIME UNSPECIFIED), THE PATIENT REPORTEDLY WAS ADMINISTERED GLUCOSE TABLETS/GLUCOSE GEL AS TREATMENT BY A NON-HEALTH CARE PROFESSIONAL. THE REASON FOR TREATMENT, HOWEVER, IS UNCLEAR. IT IS ALSO NOT KNOWN IF THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT WITH ANOTHER DEVICE PRIOR TO RECEIVING TREATMENT. DURING TROUBLESHOOTING, THE CSR NOTED THAT ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THERE IS NO EVIDENCE THE PATIENT DEVELOPED ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE THE ALLEGED ISSUE AND REPORTEDLY RECEIVED TREATMENT FOR AN ACUTE COMPLICATION FOR DIABETES BY A NON-HEALTH CARE PROFESSIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention