BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2230534 · Received September 1, 2011

    Report

    Report Number
    2939301-2011-08468
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE ON HER ONETOUCH ULTRA METER DUE TO IT REVERTING TO THE SET UP MODE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011, AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT STATED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 12PM. THE PATIENT REPORTED THAT WHEN SHE INSERTED A TEST STRIP TO PERFORM A TEST, THE SUBJECT METER WENT INTO THE "SET UP MODE" INSTEAD OF PROMPTING FOR A BLOOD SAMPLE. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH METFORMIN PILLS ALONG WITH MEDICATION FOR OTHER HEALTH CONDITIONS. THE PATIENT ADVISED THE CCA THAT SHE CONTINUED WITH HER NORMAL DIABETES MEDICATION AND DID NOT MAKE ANY CHANGES TO HER DIABETES MANAGEMENT ROUTINE AFTER THE ALLEGED ISSUE OCCURRED. THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF "DIZZINESS AND FREQUENT URINATION" IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED. THE PATIENT STATED THAT SHE WAS TAKEN TO THE HOSPITAL "TWO WEEKS AGO" (DATE AND TIME UNSPECIFIED) AND WAS TESTED USING A HOSPITAL METER. THE PATIENT INFORMED THE MSS THAT THE READING WAS "HIGH" BUT WAS UNABLE TO PROVIDE THE RESULT. SHE STATED SHE WAS TREATED WITH AN UNKNOWN TYPE AND DOSE OF INSULIN AND WAS HOSPITALIZED. THE PATIENT THEN INFORMED THE MSS THAT SHE COULD NOT REMEMBER ALL THE DETAILS AND WAS NOT ABLE TO ANSWER ANY ADDITIONAL QUESTIONS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE BATTERY HAD BEEN REMOVED JUST PRIOR TO ATTEMPTING THE BLOOD TEST AND THEREFORE THE METER NEEDED TO BE RESET. THE CCA ASSISTED THE PATIENT WITH RE-SETTING THE SUBJECT METER AND THE ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND WAS HOSPITALIZED AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3054375

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R