BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2771202 · Received October 3, 2012

    Report

    Report Number
    3008382007-2012-04746
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 10, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, DEVICE EVALUATION: THE TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE 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

    (B)(4): THE REPORTED ISSUE WAS UNFOUNDED DURING INVESTIGATION WITH TEST STRIPS. HOWEVER, THE METER WAS FOUND TO HAVE CRACKED CASE AND SPC PIN ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.DEVICE RETURNED TO MFG DATE:TEST STRIPS- 9/20/2012,METER- 9/27/2012.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION CONFIRMED THE ALLEGED ERROR MESSAGE IN THE METER'S ERROR LOG; HOWEVER, THE ERROR MESSAGE WAS NOT REPRODUCIBLE DURING TESTING. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING A ONETOUCH VERIO IQ METER WAS DISPLAYING AN ERROR 2 MESSAGE. 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. THE TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4)2012 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT ALLEGED METER WAS DISPLAYING AN ERROR 2 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 3318780

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR