BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4622119 · Received March 22, 2015

    Report

    Report Number
    2939301-2015-11296
    Event Type
    Malfunction
    Date Received
    March 22, 2015
    Report Date
    March 20, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (06/09/2015). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 4/20/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/25/2015 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.

    Additional Manufacturer Narrative · 1

    CORRECTION 9/8/2015: ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THE ALLEGED ISSUE OCCURRED AT DURING THE MORNING ON (B)(6) 2015. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿211, 273 AND 323MG/DL¿ WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REGULATES THEIR DIABETES BY TAKING INSULIN (NO ADJUSTMENTS), AND DENIED MAKING ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT ROUTINE IN THE LEAD UP TO THE ALLEGED PRODUCT ISSUE. IT WAS NOTED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AS A RESULT OF THE ALLEGED PRODUCT ISSUE, BUT THE PATIENT STATED THAT THEY RECEIVED ¿40 UNITS LANTUS INSULIN¿ FROM THEIR VISITING NURSE AT 8AM ON (B)(6) 2015. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE UNIT OF MEASURE WAS SET CORRECTLY, AND THE PRODUCTS WERE REQUESTED BACK FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ THE PATIENT¿S METER HAS BEEN RETURNED ON 4/24/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/5/2015 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192336 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3695470

    Patients

    Seq Age Sex Outcome Treatment
    1