BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2162722 · Received July 14, 2011

    Report

    Report Number
    2939301-2011-05803
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2011 (UNKNOWN TIME). THE PATIENT CLAIMED HE OBTAINED AN ALLEGED HIGH BLOOD GLUCOSE READING "80MG/DL" WITH THE SUBJECT METER. HE THEN COMPARED THIS RESULT WITH ANOTHER METER THAT GAVE A READING OF "47MG/DL". BOTH RESULTS WERE TAKEN GREATER THAN 30 MINUTES APART. THE PATIENT REPORTED HE MANAGES HIS DIABETES WITH INSULIN AND ORAL MEDICATION. THE PATIENT STATED THAT HE TOOK FOOD/DRINK DUE TO THE PRODUCT ISSUE. THE PATIENT REPORTED THAT HE BECAME "SOAKING WET" AND WAS "FALLING DOWN" AFTER THE PRODUCT ISSUE. THE PATIENT REPORTED THAT HE SELF TREATED WITH FOOD AND DRINK AS A RESULT OF THE ISSUE. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R