BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4154342 · Received October 9, 2014

    Report

    Report Number
    2939301-2014-26891
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    October 1, 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
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    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 HIS ONE TOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS AND TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ¿8 WEEKS AGO¿. AT UNSPECIFIED DATES/TIMES, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿261, 227, 270, 236, 200, 314, 384, AND OVER 600 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT ALLEGED THAT THESE READINGS READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND OR NORMAL RESULTS. THE PATIENT ALSO MENTIONED, AT AN UNSPECIFIED DATE/TIME, HE OBTAINED A BLOOD GLUCOSE READING OF ¿267 MG/DL¿ WITH THE SUBJECT METER AND ¿119 MG/DL¿ WITH ANOTHER DEVICE (FREESTYLE), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE) AND INSULIN (UNKNOWN TYPE) AND STATED HE TOOK AN INCREASED DOSE OF INSULIN (UNKNOWN TYPE AND DOSAGE) IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE PATIENT STATED, ¿A FEW WEEKS BEFORE¿ CONTACTING LFS, HE WENT INTO HIS DOCTOR¿S OFFICE FOR A VISIT. THE PATIENT MENTIONED THAT HIS HEALTH CARE PROFESSIONAL (HCP) ¿INCREASED HIS INSULIN¿; HOWEVER, THE PATIENT DID NOT PROVIDE THE TYPE OF INSULIN USED OR DOSAGE. THE PATIENT MENTIONED HIS BLOOD GLUCOSE WAS TESTED WITH THE DOCTOR¿S/CLINIC METER AND OBTAINED A READING OF ¿130 MG/DL¿. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AT THE TIME TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 SUBJECT METER DID NOT MEET LFS ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636123 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3635196

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR