BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4810139 · Received June 2, 2015

    Report

    Report Number
    2939301-2015-22181
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 22, 2015
    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.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

    FOLLOW-UP # 2 - DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN 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 (B)(4) ALLEGING THAT HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN AT THE END OF (B)(6) 2015 (DATE/TIME NOT PROVIDED). THE PATIENT STATED THAT SHE OBTAINED A RESULT OF "8.7 MMOL/L" USING THE SUBJECT METER COMPARED TO A RESULT OF "6.0 MMOL/L" OBTAINED FROM ANOTHER DEVICE, BOTH RESULTS TAKEN WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. THE PATIENT MANAGES HER DIABETES WITH ORAL DIABETES MEDICATIONS WITH DIET AND/OR EXERCISE. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF MEDICATIONS (INCLUDING SLIDING SCALE) AT THE END OF (B)(6) 2015 (DATE/TIME NOT PROVIDED) IN RESPONSE TO THE ALLEGED INACCURACY. THE PATIENT CLAIMED THAT NO SYMPTOMS DEVELOPED. THE PATIENT STATED THAT SHE VISITED HER DOCTOR AT THE END OF (B)(6) 2015 (DATE/TIME NOT PROVIDED) AND HER DIABETES MEDICATIONS WERE CHANGED TO 500MG PER DAY OF JANUMET, BASED ON THE PATIENT'S A1C TEST RESULT AND THE RESULTS FROM THE SUBJECT METER. THE PATIENT DENIED HAVING TESTED HER BLOOD GLUCOSE ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE TEST STRIPS HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM A WALK-THROUGH TEST, THE TEST STRIPS WERE NOT IDENTIFIED AS COUNTERFEIT/SUSPECT, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THERE IS NO EVIDENCE THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AND THERE WAS NO TREATMENT FOR A SEVERE HIGH OR LOW BLOOD GLUCOSE EXCURSION. THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354962 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3725398

    Patients

    Seq Age Sex Outcome Treatment
    1