BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2141801 · Received June 27, 2011

    Report

    Report Number
    2939301-2011-05272
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 THAT HER ONETOUCH ULTRA METER WAS DISPLAYING THE BATTERY ICON SYMBOL. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2011. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON PILLS WITH DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE CONTINUED TO ADMINISTER HER USUAL DOSE OF MEDICATION (TYPE/ DOSE NOT SPECIFIED), DRANK HER ORANGE JUICE, AND ATE HER SANDWICH ON THE EVENING OF (B)(6) 2011. THE PATIENT REPORTED 2 DAYS AFTER THE ALLEGED ISSUE BEGAN, SHE BECAME SHAKY AND WAS TREMBLING. IN SPITE OF HER SYMPTOMS, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER AND THERE WAS NO MISUSED OF THE METER. THE METER REQUIRED A BATTERY REPLACEMENT; HOWEVER THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE AT THE TIME. 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 REPORTED ISSUE 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3102006

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening