BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 6875022 · Received September 19, 2017

    Report

    Report Number
    3008382007-2017-22561
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 12, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER UNSPECIFIED ONETOUCH METER WAS READING INACCURATELY LOW WHEN TESTED WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT 8:30 P.M., ON (B)(6) 2017. THE PATIENT CLAIMED OBTAINING A CONTROL SOLUTION RESULT OF ¿80 MG/DL¿ WITH THE UNSPECIFIED ONETOUCH METER WHICH FELL OUT WITH THE RANGE OF 122-163 MG/DL PRINTED ON THE TEST STRIP VIAL. THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTED INSULIN (TYPE AND DOSE NOT REPORTED) AND CLAIMED THAT IN RESPONSE TO THE ALLEGED ISSUE, SHE CONSUMED MORE FOOD AND/OR DRINK. THE PATIENT REPORTED THAT IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, SHE ¿PASSED OUT¿. THE PATIENT STATED THAT SHE SELF-TREATED BY ADMINISTERING A GLUCAGON INJECTION. THE PATIENT CONFIRMED THAT HER BLOOD GLUCOSE WAS TESTED USING ANOTHER DEVICE; HOWEVER, SHE WAS UNABLE TO RECALL THE RESULT OBTAINED. AS THE PATIENT WAS UNABLE TO PROVIDE THE METER BRAND; IT WAS NOT POSSIBLE FOR THE CSR TO WALK THE PATIENT THROUGH TROUBLESHOOTING THE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655288 UNKNOWN METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4029035

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R