BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2770483 · Received October 3, 2012

    Report

    Report Number
    3008382007-2012-04718
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 7, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTER ERROR MESSAGE COULD NOT BE REPRODUCED. 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) FROM THE UNITED STATES ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS PROMPTING AN ERROR 4 MESSAGE. PER THE ONETOUCH VERIO IQ USER GUIDE THIS MESSAGE PROMPTS WHEN THERE IS A STRIP FILL PROBLEM. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THEIR COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT CLAIMED THAT THE SUBJECT METER WAS PROMPTING AN ERROR 4 MESSAGE. THERE IS NO EVIDENCE THAT THE ALLEGED ISSUE 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

    Patients

    Seq Age Sex Outcome Treatment
    1