BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3102533 · Received May 9, 2013

    Report

    Report Number
    3008382007-2013-10772
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/26/2013) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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

    THE SUBJECT METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (B)(4), ALLEGING THE METER WAS READING INACCURATELY LOW COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA) AS WELL AS FROM ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WITH ADDITIONAL FOLLOW UP QUESTIONS ON (B)(6) 2013. THE PATIENT REPORTED THE ALLEGED ISSUE HAD BEEN RECURRING INTERMITTENTLY FOR MONTHS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED THE EVENING BEFORE THE ISSUE OCCURRED, SHE MAY HAVE FORGOTTEN TO EAT SOMETHING BEFORE BED. THE PATIENT STATES THAT SHE HAS MEMORY PROBLEMS. THE PATIENT REPORTED 5-7 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, SHE HAD SYMPTOMS OF "HEADACHE, HOT AND SWEATY". THE PATIENT REPORTED SHE TESTED ON THE LFS METER AND OBTAINED A READING OF "3.0MMOL/L" AND TESTED ON A CONTOUR METER 5 MINUTES LATER AND OBTAINED A READING OF "4MMOL/L". BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=15% OR <=0.67MMOL/L. THE PATIENT REPORTED SHE NORMALLY TESTS 4 TIMES A DAY AND AS NEEDED WHEN SHE IS FEELING ILL. THE PATIENT REPORTED SHE USES A COMBINATION OF METFORMIN (TWICE A DAY) AND NOVOLIN 40/60 MIX (TWICE A DAY) ON A SLIDING SCALE. THE PATIENT REPORTED IN RESPONSE TO HER SYMPTOMS SHE TREATED HERSELF WITH SOMETHING SUGARY. THE PATIENT REPORTED SHE BELIEVES HER SYMPTOMS WERE CAUSED BY FORGETTING TO EAT SOMETHING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAME, AND SHE WAS USING THE CORRECT TESTING STEPS. THE PATIENT REPORTED HER TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. HOWEVER, A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT REPORTED, SHE BELIEVED HER SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA WERE CAUSED BY A CHANGE IN HER DIET, AND NOT FROM THE ALLEGED METER ISSUE. IN ADDITION THE REPORTED TREATMENT AND SYMPTOMS CORRELATED WITH THE ALLEGED INACCURATE LOW READINGS. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT MADE A METER VS. METER COMPARISON WHICH MEETS LFS' CRITERIA FOR ACCURACY REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204274 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3368437

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR