BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3914810 · Received July 4, 2014

    Report

    Report Number
    2939301-2014-16458
    Event Type
    Injury
    Date Received
    July 4, 2014
    Report Date
    June 19, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/10/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 07/08/2014 WITH THE FOLLOWING FINDINGS:THE METER 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH VERIO IQ WAS DISPLAYING A BATTERY INDICATOR WHEN ATTEMPTING TO TEST. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/REPORTER FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT/REPORTER CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY 1 WEEK PRIOR TO CONTACTING LFS FOR ASSISTANCE. THE PATIENT¿S DIABETES MANAGEMENT WAS NOT SPECIFIED BUT HE REPORTEDLY CONTINUED WITH HIS USUAL ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. ON AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿BLURRED VISION, SWEATING, AND BECAME UNCONSCIOUS.¿ IT WAS NOT CLEAR IF THE SYMPTOMS DEVELOPED BEFORE OR AFTER THE ALLEGED ISSUE BEGAN. IT WOULD HAVE BEEN HELPFUL TO UNDERSTAND IF THE ALLEGED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE FORM OF HCP TREATMENT IS NOT KNOWN. THE REPORTER INDICATED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON ANOTHER UNKNOWN DEVICE AT AN UNKNOWN TIME. THE RESULT OBTAINED WAS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME; THE BATTERY DID NOT NEED REPLACING BASED ON THE USE OF METER. THE ISSUE REMAINED UNRESOLVED AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT REPORTEDLY SUFFERED A SERIOUS INJURY THAT REQUIRED UNSPECIFIED HCP TREATMENT AND THE ALLEGED METER ISSUE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392723 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3638743

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R