BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 5245322 · Received November 24, 2015

    Report

    Report Number
    2939301-2015-50248
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Report Date
    November 12, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2. THE LAY USER/PATIENTS METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2015 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON THE MORNING OF (B)(6). THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "254, 197 AND 187MG/DL" ON THE SUBJECT METER AND "122MG/DL" ON AN UNKNOWN DOCTOR'S METER, OBTAINED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT REPORTED CONTINUING TO TAKE THEIR USUAL DOSE OF METFORMIN IN RESPONSE TO THE ALLEGED HIGH READINGS. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS. THE PATIENT REPORTED VISITING THEIR HCP WHERE THEY WERE ADVISED TO OBTAIN A NEW METER. THE PATIENT DID NOT REPORT ANY MEDICAL TREATMENT. THE CCA WAS UNABLE TO FULLY TROUBLESHOOT THE ISSUE AS THE PATIENT DID NOT HAVE TEST STRIPS AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AND DID NOT REPORT ANY MEDICAL TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777670 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR