BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4143467 · Received October 6, 2014

    Report

    Report Number
    2939301-2014-26462
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 25, 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
    TX, 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¿S REPORTER CONTACTED LIFESCAN (LFS) AND ALLEGED THE PATIENTS ONE TOUCH VERIOIQ METER READ INACCURATELY ERRATIC . THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THE ISSUE BEGAN APPROXIMATELY 2 MONTHS AGO. THE PATIENT ALLEGEDLY OBTAINED INACCURATE ERRATIC RESULTS OF ¿153 AND 105 MG/DL¿ WITH THE SUBJECT METER ON (B)(4) 2014 AT 4.23AM AND 4.24AM RESPECTIVELY. BASED ON STATISTICALLY METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES EXCEED LIFESCAN¿S CRITERIA FOR PRECISION. THE PATIENT MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE ALONE. THE REPORTER ALLEGED THE PATIENT INCREASED HIS EXERCISE REGIME AND DECREASED HIS FOOD AND/OR DRINK INTAKE IN RESPONSE TO THE INACCURATE ERRATIC RESULT, APPROXIMATELY 7 WEEKS AGO. THE REPORTER CLAIMS THE PATIENT DEVELOPED SYMPTOMS OF ¿STRESS AND ANXIETY¿ APPROXIMATELY 1 WEEK AFTER THE PRODUCT ISSUE BEGAN. THE REPORTER ALLEGED THE PATIENT HAD A DOCTOR¿S OFFICE VISIT WITHIN THE LAST MONTH. THE REPORTER DENIED THE PATIENT RECEIVED TREATMENT DUE TO THE PRODUCT ISSUE. THE REPORTER ALLEGED THE PATIENT TESTED HIS BLOOD GLUCOSE ON OTHER DEVICES ON UNSPECIFIED DATE/TIMES, WITH RESULTS OF ¿128MG/DL¿ (ACCUCHECK), ¿108MG/DL¿ (FREESTYLE) AND ¿116 MG/DL¿ (ACCUCHECK COMPAC PLUS). AT THE TIME OF TROUBLE SHOOTING, THE CCA WAS ABLE TO CONFIRM THE CORRECT UNIT OF MEASURE WAS USED AND THE CORRECT SAMPLE SITE WAS USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE SUBJECT METER CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA AFTER OBTAINING THE INACCURATE ERRATIC RESULTS, NOR DID HE RECEIVE MEDICAL INTERVENTION. THERE IS NO EVIDENCE THE PATIENT WAS ADMINISTERED WITH INAPPROPRIATE SELF-TREATMENT DUE TO THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623185 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3608572

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR