BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2032491 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02673
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). 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 AT DINNER TIME. THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "304 MG/DL" WITH THE SUBJECT METER. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER) AND IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT CONTINUED WITH HER USUAL DOSE OF MEDICATION AT 5:30PM AND ADMINISTERED 34 UNITS OF NOVOLOG. ONE HOUR AFTER THE REPORTED ISSUE OCCURRED, THE PATIENT CLAIMED SHE DID NOT FEEL RIGHT AND WAS SWEATING. THE PATIENT, HOWEVER, DENIED RECEIVING ANY TREATMENT FOLLOWING THE ALLEGED INACCURATE HIGH ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT; HOWEVER, THE CSR NOTED THAT THE SUBJECT METER WAS NOT PROPERLY SET TO THE CORRECT CODE NUMBER (PER OWNER'S BOOKLET RECOMMENDATION). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3080601

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening