BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2161400 · Received July 13, 2011

    Report

    Report Number
    2939301-2011-05801
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. 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 6:48PM. AT AN UNSPECIFIED TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "176, 234, AND 215MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT'S TESTING FREQUENCY IS NOT SPECIFIED AND THE PATIENT'S USUAL BLOOD GLUCOSE RANGE IS NOT KNOWN. IT IS ALSO NOT KNOWN IF THE PATIENT HAD MADE ANY CHANGES TO HER DIABETES MANAGEMENT, MEALS, OR ACTIVITY LEVEL PRIOR TO THE START OF THE ALLEGED ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DOES NOT MANAGE HER DIABETES WITH INSULIN OR ORAL MEDICATION. TWO MINUTES AFTER THE ALLEGED ISSUE OCCURRED THE PATIENT STATED SHE CONSUMED LESS FOOD/DRINK AND SUBSEQUENTLY, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SWEATING AND HEADACHE APPROXIMATELY THREE TO FOUR HOURS LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION/TREATMENT FOLLOWING THE ONSET OF HER SYMPTOMS. IT IS NOT KNOWN IF THE PATIENT ASSOCIATED HER SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE, IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOMS IMPROVED, AND IT IS NOT KNOWN IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. 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. 3129052

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening