BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2183240 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06577
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT ON (B)(6) 2011 HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO RECEIVING AN "ERROR 2" ERROR MESSAGE. PER THE ONE TOUCH ULTRA METER OWNER'S BOOKLET AN ERROR 2 MESSAGE COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THE REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HIS DIABETES USING HUMALOG INSULIN, 15 UNITS BEFORE BREAKFAST AND 7 UNITS BEFORE DINNER ON A FIXED SCHEDULE. THE PATIENT REPORTEDLY TOOK HIS USUAL DOSE OF MEDICATION AFTER ATTEMPTING TO TEST WITH THE SUBJECT METER. THE FOLLOWING DAY IN THE AFTERNOON, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "SWEATING" AND DENIED RECEIVING ANY MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS APPLYING THE BLOOD SAMPLE TO THE STRIP PRIOR TO INSERTING THE TEST STRIP INTO THE METER. THE PATIENT WAS ABLE TO SUCCESSFULLY RETEST OVER THE PHONE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3153800

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR