BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 7841179 · Received September 4, 2018

    Report

    Report Number
    3008382007-2018-02456
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 24, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE TEST STRIP LOT CONCLUDED THAT THIS PARTICULAR LOT BREACHED THE THRESHOLDS SET FOR ESCALATION. LIFESCAN THEREFORE CONDUCTED PERFORMANCE TESTING WITH CONTROL SOLUTION ON RETAINED TEST STRIPS FROM THAT LOT. THE RETAINED TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. 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) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH SELECT SIMPLE METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN THE FIRST WEEK OF (B)(6) 2018. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE LOW BLOOD GLUCOSE READINGS OF ¿117 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT REPORTED THAT AT THIS TIME HE WAS NOT TAKING ANY MEDICATION TO MANAGE HIS DIABETES. THE PATIENT STATED THAT ON (B)(6) 2018, HE WAS NOT FEELING WELL, HE WAS UNABLE TO CONFIRM EXACT SYMPTOMS. IN RESPONSE TO NOT FEELING WELL, HE ATTENDED HIS DOCTOR. A BLOOD GLUCOSE RESULT OF ¿526 MG/DL¿ WAS OBTAINED ON THE DOCTOR¿S METER. THE PATIENT WAS ADVISED TO ATTEND THE HOSPITAL, AND WAS ADMITTED, AND TREATED WITH INSULIN AND OTHER TREATMENT. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682099 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4305008

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R