BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3250264 · Received July 26, 2013

    Report

    Report Number
    3008382007-2013-21219
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 22, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/13/2013)-PRODUCT EVALUATION: THE ASSOCIATED TEST STRIPS WERE RETURNED ON 07/31/2013 AND ANALYSIS COMPLETED ON 08/07/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE TEST STRIPS MET SPECIFICATIONS FOR TESTING. NO ISSUES WERE IDENTIFIED DURING INVESTIGATION. 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

    FOLLOW-UP # 2 ¿ (09/18/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/5/2013 AND 9/10/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED ON AN UNSPECIFIED DATE AT APPROXIMATELY 7:30PM SHE TESTED ON THE SUBJECT METER AND OBSERVED A READING OF ¿279MG/DL¿ WHICH SHE FELT WAS HIGH BASED ON HER FEELINGS/NORMAL READINGS. THE PATIENT WAS NOT REPORTEDLY TAKING ANY MEDICATIONS TO MANAGE HER DIABETES AND STATED THAT WHILE TESTING/IMMEDIATELY AFTER, SHE DEVELOPED SYMPTOMS OF ¿SWEATING.¿ SHE REPORTEDLY RE-CHECKED HER BLOOD GLUCOSE ON A RELATIVE¿S METER (ONETOUCH BRAND) AND OBTAINED A READING OF ¿59MG/DL.¿ BOTH TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/ OR <=30 MG/DL. THE PATIENT REPORTED THAT SHE THEN ATE DINNER AND FELT BETTER AFTERWARDS; NO OTHER FORM OF TREATMENT WAS REQUIRED. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351185 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3442737

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR