BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4161141 · Received October 10, 2014

    Report

    Report Number
    2939301-2014-27101
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    October 8, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/25/2015 DEVICE EVALUATION.THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 11/11/2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/5/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED.THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAD NO TESTING PERFORMED, AS THE COMPLAINT IS RELATED TO A METER ISSUE. 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

    CORRECTION TO INCIDENT DESCRIPTION: ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) TO REPORT THAT HER ONETOUCH VERIOIQ METER DISPLAYED AN ¿APPLY SAMPLE¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THE PROBLEM WITH THE METER STARTED ¿ON (B)(6) 2014, AROUND 10:00 PM¿, WHEN SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE LEVELS AND OBTAINED THE ALLEGED ERROR MESSAGE. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). SHE DENIED TAKING ANY ACTION IN RESPONSE TO HER REGULAR DIABETES MANAGEMENT REGIMEN ROUTINE AS A RESULT OF THE MESSAGE SHE OBTAINED. HOWEVER, SHE ALLEGED, AS A RESULT OF BEING UNABLE TO OBTAIN A READING WITH THE METER, SHE EXPERIENCED ¿ANXIETY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOM. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE METER AND TEST STRIPS HAD BEEN IN USE SINCE (B)(6) 2014, AND THE METER WAS NOT BEING USED FOR THE FIRST TIME. THE CSR ALSO NOTED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS, THE CORRECT TESTING STEPS AND THAT THE TEST STRIPS COMPLETELY DREW IN THE SAMPLE. HOWEVER, WHEN THE CSR WALKED THE PATIENT THROUGH A RETEST, THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PATIENT¿S REPORTED SYMPTOMS DO NOT MEET LFS¿ SERIOUS INJURY CRITERIA. ADDITIONALLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR SYMPTOMS SUGGESTIVE OF A SEVERE DIABETES EXCURSION. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED ERROR MESSAGE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4) , ALLEGING APPLY SAMPLE - METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637490 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3674272

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR