BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 6140485 · Received December 2, 2016

    Report

    Report Number
    3008382007-2016-61947
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 15, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS BOTH PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING SENT TO CORRECT INFORMATION PREVIOUSLY SUBMITTED. THE ALERT DATE OF FOLLOW-UP # 1 SHOULD HAVE STATED (B)(6) 2016

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST BEGAN AT 12 A.M., ON (B)(6) 2016. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿220, 340 AND 120 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. THE PATIENT REPORTED THAT SHE DEVELOPED THE SYMPTOM OF ¿SWEATING¿ PRIOR TO OBTAINING THE ALLEGED INACCURATE ERRATIC BLOOD GLUCOSE READINGS AND THAT AT 12:20 A.M., SHE SELF-TREATED HER SYMPTOM BY DRINKING SOME LIQUIDS. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THAT THE CORRECT TESTING METHOD WAS BEING FOLLOWED AND THAT AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS. THE CSR CONFIRMED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CSR ALSO DOCUMENTED THAT THE PATIENT DID NOT HAVE TESTING SUPPLIES AVAILABLE TO TEST THE SUBJECT METER. THE SUBJECT PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE WHILST USING THE SUBJECT DEVICE, THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT. THE ALLEGED ISSUE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE ONSET OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791763 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4033324

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R