BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3190788 · Received June 26, 2013

    Report

    Report Number
    3008382007-2013-18537
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/10/2013).THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/12/2013 AND 6/15/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED.CUSTOMER RETURNED EMPTY TEST STRIP VIAL. TESTING COULD NOT BE PERFORMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 WHEN COMPARED TO HER FEELING/ NORMAL RESULT(S). 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, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿85 AND 78MG/DL¿ (AT 7:40AM), ¿59MG/DL¿ ( AT 10:30AM), AND ¿91MG/DL¿ (AT 10:45AM). 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, IMPAIRED SPEECH, HEADACHE¿ 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. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CSR ALSO NOTED THE PATIENT PERFORMED THE QUALITY CONTROL SOLUTION TEST THAT PASSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER RETURNED HAS THE SERIAL NUMBER OF (B)(4). THE METER WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDING: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER FUNCTIONED PROPERLY. THE PATIENT HAD ALSO RETURNED AN EMPTY VIAL OF TEST STRIPS; STRIP EVALUATION NOT POSSIBLE. 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
    290365 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