BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3822557 · Received May 21, 2014

    Report

    Report Number
    2939301-2014-11972
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER READ 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 ON (B)(6) 2014, AT 6PM, SHE OBTAINED BLOOD GLUCOSE READINGS OF ¿188 AND 229MG/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. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE. THE PATIENT REPORTEDLY CONSUMED LESS FOOD/DRINK THAT DAY; HOWEVER, THE TIME OF HER ACTION IS NOT SPECIFIED. ACCORDING TO THE CSR¿S DOCUMENTATION, ONE TO TWO MINUTES AFTER THE PRODUCT ISSUE OCCURRED THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATING AND SHAKING. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE OCCURRED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING: THE PATIENT¿S TESTING FREQUENCY AND NORMAL BLOOD GLUCOSE RANGE; PRIOR TO THE ALLEGED ISSUE, WHAT WAS HER PREVIOUS READINGS THAT DAY (WITH THE SUBJECT METER) AND WHAT SHE BELIEVE COULD HAVE CAUSED HER SYMPTOMS; WHAT ACTION THE PATIENT TOOK IN RESPONSE TO THE ALLEGED ISSUE; IF THE PATIENT ASSOCIATED HER REPORTED SYMPTOMS WITH HIGH OR LOW BLOOD GLUCOSE; WHAT THE PATIENT DID TO TREAT HER REPORTED SYMPTOMS; AND WHEN DID HER SYMPTOMS SUBSIDE. 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. 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
    303778 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening