BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2801668 · Received October 23, 2012

    Report

    Report Number
    3008382007-2012-05431
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCT(S) HAVE NOT YET BEEN EVALUATED; LFS WILL EVALUATE IT/THEM AND INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (SUBMISSION 12/04/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE METER AND TEST STRIPS WITH THE COMPLAINT ON (B)(4) 2012 AND (B)(4) 2012, RESPECTIVELY. INVESTIGATION WAS COMPLETED WITH THE RETURNED METER ON (B)(4) 2012. THE ALLEGED ERROR MESSAGE WAS CONFIRMED IN THE METER'S ERROR LOG; HOWEVER, THE ERROR MESSAGE WAS NOT REPRODUCIBLE DURING TESTING. INVESTIGATION IS ANTICIPATED WITH THE RETURNED TEST STRIPS AND IS NOT COMPLETED AT THIS TIME.

    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 2 MESSAGE. PER THE ONETOUCH VERIO IQ USER GUIDE THE ERROR 2 MESSAGE PROMPTS WHEN THERE IS A PROBLEM WITH THE METER OR TEST STRIP. 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 2 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 3234554

    Patients

    Seq Age Sex Outcome Treatment
    1