BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3070548 · Received April 22, 2013

    Report

    Report Number
    3008382007-2013-08547
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH WITH BLOOD AND CONTROL SOLUTION. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED ON AN UNKNOWN DATE/TIME SHE TESTED ON THE SUBJECT METER AND IT READ "HI" WHICH SHE FELT TO BE INACCURATE BASED ON HER NORMAL READINGS/FEELINGS. SHE THEN PERFORMED A CONTROL SOLUTION TEST AND CLAIMED SHE OBTAINED A READING OF "590 MG/DL", EXCEEDING THE UPPER LIMIT OF THE CONTROL RANGE. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES AND SHE DENIED DEVELOPING SYMPTOMS BUT CLAIMED SHE REQUIRED UNKNOWN TREATMENT. SHE DID NOT PROVIDE ANY FURTHER DETAILS OF THE TYPE OF TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THAT THE TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. NO FURTHER TROUBLESHOOTING COULD BE PERFORMED BECAUSE THE PATIENT DISCONNECTED FROM THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO SUFFICIENT EVIDENCE THAT THE ALLEGED ISSUES CAUSED THE PATIENT TO SUFFER A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY ISSUES REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171888 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302196

    Patients

    Seq Age Sex Outcome Treatment
    1