BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3190941 · Received June 26, 2013

    Report

    Report Number
    3008382007-2013-18538
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (SERIAL #) INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, 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 IN (B)(6) 2013. THE PATIENT¿S TESTING FREQUENCY IS NOT KNOWN, IT IS NOT SPECIFIED WHAT THE PATIENT¿S NORMAL BLOOD GLUCOSE RANGE IS, AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ON (B)(6) 2013, (AT 1:55PM), THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿91, 80, 72MG/DL¿ WITH THE SUBJECT METER, REPORTEDLY PERFORMED WITHIN THE SAME TIME FRAME 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 DOES NOT MANAGE HER DIABETES WITH INSULIN OR ORAL MEDICATION AND IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿SHAKINESS CONFUSED SPEECH¿ AT AN UNKNOWN TIME LATER. PRIOR TO THE ONSET OF AND/OR DURING HER REPORTED SYMPTOMS, IT IS NOT CLEAR WHAT THE PATIENT¿S BLOOD GLUCOSE READING WAS WITH THE SUBJECT METER; IT IS ALSO NOT KNOWN IF THE PATIENT HAD MADE ANY CHANGES TO HER DIABETES MANAGEMENT, ACTIVITY LEVEL, AND/OR MEALS BEFORE HER SYMPTOMS BEGAN. ACCORDING TO THE CSR¿S DOCUMENTATION, ON (B)(6) 2013, (TIME NOT SPECIFIED), THE PATIENT REPORTEDLY CONSUMED FOOD AND/OR DRINK AS TREATMENT; HOWEVER, THE PATIENT¿S BLOOD GLUCOSE READING (WITH THE SUBJECT METER) PRIOR TO SELF-TREATMENT IS NOT KNOWN. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. THE CSR ALSO NOTED THE PATIENT PERFORMED A QUALITY CONTROL TEST THAT PASSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290291 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3334860

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R