BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4242192 · Received November 11, 2014

    Report

    Report Number
    2939301-2014-30259
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    November 4, 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 - 3/9/2015 DEVICE EVALUATION. THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 1/9/2015 AND 2/3/2015, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/21/2015 AND 2/17/2015 RESPECTIVELY WITH THE FOLLOWING FINDINGS: ERROR MESSAGES 4 OBSERVED IN THE ERROR LOG, BUT THE ERRORS WERE NOT REPRODUCED DURING THE INVESTIGATION. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. WHEN TEST STRIPS WERE TESTED WITH CONTROL SOLUTION, AN ERROR 4 WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. 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

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS DISPLAYING AN ¿ERROR 4¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6), 2014 AT APPROXIMATELY 10:00AM. APPROXIMATELY 30 MINUTES PRIOR TO THE ALLEGED METER ISSUE, THE PATIENT STATED SHE BEGAN ¿SWEATING¿. DURING THE FOLLOW-UP CALL, THE PATIENT STATED SHE WAS INITIALLY UNSURE IF HER REPORTED SYMPTOM WAS ¿HOT FLUSHES¿ DUE TO HER AGE. IN RESPONSE TO HER SYMPTOM, THE PATIENT REPORTED SELF-TREATING WITH ORANGE JUICE APPROXIMATELY 15 MINUTES AFTER ATTEMPTING TO TEST HER BLOOD GLUCOSE WITH THE SUBJECT METER. THE PATIENT CLAIMED NO OTHER BLOOD GLUCOSE TESTS WERE PERFORMED ON ANY OTHER DEVICE. DURING THE FOLLOW-UP CALL, THE PATIENT STATED SHE TESTS HER BLOOD GLUCOSE 7 TIMES A DAY (BEFORE AND AFTER EACH MEAL AND PRIOR TO BEDTIME). THE PATIENT REPORTED THAT HER NORMAL BLOOD GLUCOSE RANGE IS BETWEEN 6.5-9.5 MMOL/L. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. DURING THE FOLLOW-UP CALL, THE PATIENT ATTRIBUTED THE ONSET OF HER SYMPTOM TO A NEW DIABETES MEDICATION (ONGLYZA) THAT SHE BEGAN TO TAKE AT 7:30AM THE DAY PRIOR TO THE ALLEGED METER ISSUE. THE PATIENT STATED SHE HAS SINCE STOPPED THE MEDICATION AS IT WAS CAUSING HER TO DEVELOP HYPOGLYCEMIA WHICH IS POSSIBLE SIDE EFFECT OF THE MEDICATION. THE PATIENT CONFIRMED HER SYMPTOM OF ¿SWEATING¿ DID NOT WORSEN AS A RESULT OF BEING UNABLE TO TEST WITH THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE LFS PRODUCT AND CONFIRMED THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CSR WALKED THE PATIENT THROUGH A RETEST AND THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, ALTHOUGH THE PATIENT DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT HAD BECOME SYMPTOMATIC PRIOR TO THE ALLEGED METER ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED METER ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725541 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3658351

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR