BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3120708 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12148
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 ¿ (08/28/2013) THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT OBTAINED AN UNSPECIFIED ERROR MESSAGE ON THE REPORTED METER; SHE WAS UNABLE TO PROVIDE THE SPECIFIC ERROR MESSAGE THAT OCCURRED. AT THAT TIME THE PATIENT EXPERIENCED THE SYMPTOM OF LIGHTHEADEDNESS DUE TO HAVING A COLD; THE PATIENT IS NOT DIAGNOSED AS DIABETIC. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING A GLUCOSE TABLET; SHE DID NOT SEEK ANY MEDICAL ATTENTION. THIS WAS A NEW, OUT-OF-THE-BOX, METER; THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER WAS REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT¿S SYMPTOM OCCURRED PRIOR TO THE METER ISSUE AND WAS NOT INDICATIVE OF SEVERE INJURY. HOWEVER, AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221794 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3330670

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR