BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2760917 · Received September 26, 2012

    Report

    Report Number
    3008382007-2012-04563
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 31, 2012
    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
    SC, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2012)-DEVICE EVALUATION: THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2012 WITH THE FOLLOWING FINDING: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE EVALUATED AND ER4 WAS OBSERVED WITH CONTROL SOLUTION TESTING. THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG BUT WAS UNABLE TO REPRODUCE FAILURE IN CONTROL SOLUTION TEST. 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH VERIO IQ WAS DISPLAYING AN ERROR 4 MESSAGE. THIS COMPLAINT WAS CLASSIFIED ACCORDING TO THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT ALLEGED THE METER WAS DISPLAYING AN ERROR 4 MESSAGE. THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3246567

    Patients

    Seq Age Sex Outcome Treatment
    1