BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3050469 · Received April 10, 2013

    Report

    Report Number
    3008382007-2013-07468
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    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
    OH, 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS DISPLAYING THE APPLY SAMPLE MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN APPROXIMATELY 60 DAYS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT REPORTEDLY CONSUMED MORE FOOD/DRINK FOR A FEW MONTHS. ACCORDING TO THE CSR¿S DOCUMENTATION, IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT'S BLOOD GLUCOSE ELEVATED AND HE DEVELOPED SYMPTOMS OF FREQUENT URINATION, DRY THROAT, AND KEPT EATING. AFTER THE ONSET OF HIS REPORTED SYMPTOMS, IT IS NOT CLEAR WHAT TYPE OF TREATMENT (IF ANY) THE PATIENT RECEIVED AND IT IS ALSO NOT KNOWN WHEN THE PATIENT'S SYMPTOMS ABATED. ON AN UNSPECIFIED DATE/TIME, THE PATIENT'S HOME HEALTH/VISITING NURSE PERFORMED A BLOOD GLUCOSE TEST (RESULT NOT KNOWN), CHECKED HIS HEART, BREATHING, AND VITAL SIGNS. THE PATIENT'S BLOOD GLUCOSE WAS ALSO TESTED WITH THE HOSPITAL'S METER SOME TIME AGO AND HIS RESULT WAS REPORTEDLY GOOD. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE SUBJECT METER FOR THE FIRST TIME WHEN THE ALLEGED ISSUE OCCURRED AND THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE (PER OWNER'S BOOKLET RECOMMENDATION). HOWEVER, THE CSR NOTED THE PATIENT DID NOT HAVE HIS TESTING SUPPLIES AVAILABLE. THE ALLEGED METER ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE REPORTED SYMPTOMS, IT IS UNLIKELY THE PRODUCT ISSUE CONTRIBUTED TO THE REPORTED SYMPTOMS. 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
    153524 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR