BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3946158 · Received July 21, 2014

    Report

    Report Number
    2939301-2014-18021
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    July 14, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/10/2014). THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON 08/18/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 09/06/2014 WITH THE FOLLOWING FINDINGS:ERROR MESSAGE IS OBSERVED IN THE ERROR LOG, BUT ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH ULTRASMART METER IS GIVING AN ERROR 4 ISSUE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CA) DOCUMENTATION. THE ERROR 4 ISSUE HAS BEEN INTERMITTENT FOR THE LAST 2 WEEKS. THE PATIENT DID NOT TAKE ANY ACTION BASED ON THE ERROR 4 ISSUE DURING THE TIME OF CONCERN. ON THE DAY THE PATIENT CONTACTED LFS, SHE DEVELOPED SYMPTOMS DESCRIBED AS ¿FEELING SHAKY.¿ THERE WAS NO REPORT OF ANY REQUIRED MEDICAL INTERVENTION. DURING TROUBLESHOOTING, THE ERROR 4 ISSUE WAS NOT RESOLVED. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ERROR 4 ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424428 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3630535

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening