BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6474894 · Received April 10, 2017

    Report

    Report Number
    3008382007-2017-16751
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    March 30, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008730
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 ONETOUCH VERIO 2 METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS. THE COMPLAINT WAS CLASSIFIED BASED ON BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE CSR DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN AT APPROXIMATELY 9.26 PM ON (B)(6) 2017. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE; SELF-ADJUSTER). THE PATIENT ALLEGED OBTAINING INACCURATE HIGH RESULTS OF ¿143, 173 AND 220¿ COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. LIFESCAN DOES NOT CONSIDER THIS TO BE A VALID COMPARISON. AT AN UNKNOWN TIME PRIOR TO THE ALLEGED METER ISSUE THE PATIENT DEVELOPED THE SYMPTOMS OF "NAUSEA" AND "SHAKY." THE PATIENT IMMEDIATELY SELF TREATED THESE SYMPTOMS WITH FOOD AND DRINK. UPON INQUIRY THE PATIENT WAS ABLE TO CONFIRM THAT THE READING PRIOR TO HER SYMPTOMS WAS HIGHER THAN NORMAL AT "260 MG/DL." SHE DENIED TAKING ANY TREATMENT IN RESPONSE TO THIS READING. DURING TROUBLESHOOTING THE CSR CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THAT THE TEST STRIPS WERE STORED PROPERLY AND HAD NOT EXPIRED NOR EXCEEDED THEIR DISCARD DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258968 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4025490 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R