BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3852713 · Received June 6, 2014

    Report

    Report Number
    2939301-2014-13619
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (08/01/2014)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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) (B)(4) ALLEGING THAT THE DISPLAY ON THE ONETOUCH VERIO IQ METER IS FADING. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN APPROXIMATELY TWO MONTHS AGO AND AT THE SAME TIME THE ALLEGED DISPLAY ISSUE WAS DISCOVERED, THE PATIENT REPORTEDLY WAS FEELING SICK AND SHAKY. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED METER ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT AND THE PATIENT WAS NOT USING THE METER FIRST THE FIRST TIME. A REPLACEMENT METER WAS SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT WAS SYMPTOMATIC THE SAME TIME THE ALLEGED METER WAS DISCOVERED. THERE WAS NO INDICATION THAT THE PATIENT¿S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PRODUCT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332301 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR