BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO FLEX METER

    MDR report key: 6916582 · Received October 5, 2017

    Report

    Report Number
    3008382007-2017-22726
    Event Type
    Injury
    Date Received
    October 5, 2017
    Report Date
    October 2, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER (SCHOOL NURSE) FOR THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO FLEX METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2017, 2:28PM. THE REPORTER STATED THAT ¿ALMOST 24 HOURS LATER¿, THE PATIENT ATTENDED THE SCHOOL NURSE AS SHE WAS EXPERIENCING SYMPTOMS OF ¿HEADACHE, FATIGUE AND BLURRY VISION¿. THE REPORTER STATED THAT THE PATIENT OBTAINED ALLEGED INACCURATE ERRATIC RESULTS OF ¿210, 237, 95, 140 AND 125MG/DL¿ ON THE SUBJECT METER PERFORMED MORE THAN 20 MINUTES APART. THE REPORTED TIME DIFFERENCE OF GREATER THAN 20 MINUTES MAKES THIS COMPARISON INVALID FOR THE PURPOSES OF DETERMINING AN INACCURACY. THE REPORTER DETAILED THAT AS SHE WAS UNABLE TO OBTAIN AN ACCURATE RESULT ON THE SUBJECT METER SO SHE TESTED ON ANOTHER PATIENT¿S METER AND OBTAINED A BLOOD GLUCOSE RESULT OF 141MG/DL. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER) AND REPORTED THAT ON (B)(6) 2017, 2:31PM THEY TOOK 4 UNITS OF INSULIN IN RESPONSE TO OBTAINING THE BLOOD GLUCOSE RESULT OF 141MG/DL. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND CORRECT TESTING STEPS WERE COMPLETED. THE BLOOD SAMPLE WAS TAKEN FROM AN APPROVED SAMPLE SITE. THE TEST STRIPS WERE STORED CORRECTLY AND WITHIN THEIR EXPIRY DATE. HOWEVER, ON INSPECTION, THE CCA CONFIRMED THAT THE TEST STRIP VIAL WAS EITHER CRACKED OR BROKEN. THE REPORTER WAS UNABLE/UNWILLING TO CONFIRM IF THE CONTROL TEST HAD BEEN SELECTED MANUALLY. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT PRIOR TO THE ALLEGED PRODUCT ISSUE BEGINNING. IT CANNOT BE RULED OUT THAT THE METER DID NOT CAUSE OR CONTRIBUTE TO THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696211 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening