BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4112496 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25230
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 16, 2014
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/29/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/10/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/17/2014 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

    FOLLOW-UP # 1 ¿ (12/04/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 10/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/24/2014 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER STARTED READING INACCURATELY ¿ABOUT (B)(6) 2014¿. SHE REPORTED, ON AN UNKNOWN DATE/TIME, OBTAINING AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿265 MG/DL¿ ON THE SUBJECT METER AND ¿140 MG/DL¿ ON ANOTHER, UNSPECIFIED METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE REPORTED DIFFERENCE BETWEEN THESE RESULTS FALLS OUTSIDE LFS¿ ACCURACY CRITERIA. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE ALLEGED, ALSO ¿ABOUT (B)(6) 2014¿, CONSUMING ¿LESS FOOD/DRINK¿ IN RESPONSE TO THE ALLEGED HIGH READING. THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS AS A RESULT OF THE PROBLEM SHE EXPERIENCED. ON (B)(6) 2014, SHE ALLEGED RECEIVING TELEPHONE ADVICE FROM A HEALTHCARE PROFESSIONAL TO ¿MONITOR IT¿. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE PATIENT HAD USED AN APPROVED SAMPLE SITE. HOWEVER, SHE DID NOT HAVE CONTROL SOLUTION WITH WHICH TO TEST THE METER AND TEST STRIPS AND THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE, THE ALLEGED METER ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593370 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3542489

    Patients

    Seq Age Sex Outcome Treatment
    1