BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2980853 · Received February 27, 2013

    Report

    Report Number
    3008382007-2013-03783
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 13, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (09/02/2013).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/6/2013 AND 8/26/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE TEST STRIPS 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (08/23/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/6/2013 AND 8/17/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE 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.

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT HAS NOT BEEN RETURNED TO LIFESCAN FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH VERIO IQ METER IS GIVING INACCURATE ERRATIC READINGS OF "3.7 AND 13.7 MMOL/L." (66 MG/DL AND 246 MG/DL) THE PATIENT MANAGES HER DIABETES WITH SELF ADJUSTING INSULIN. ON THE DAY OF CONCERN, THE PATIENT REPORTEDLY DID NOT DEVELOP ANY SYMPTOMS AND REPORTEDLY ADMINISTERED SELF TREATMENT WITH FOOD/DRINK. THERE WAS NO REPORT OF ANY REQUIRED HCP MEDICAL INTERVENTION TO SUGGEST A SERIOUS INJURY. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE PATIENT DID NOT WASH HER HANDS PRIOR TO TESTING AND OBTAINING THE AFOREMENTIONED RESULTS. THE READINGS WERE TAKEN WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 1.11 MMOL/L. IN ADDITION, THE RESULTS FALL OUTSIDE THE A AND B ZONE FOR THE CONSENSUS ERROR GRID. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE ERRATIC RESULTS. THERE WAS NO SYMPTOMS AND NO REPORT OF ANY REQUIRED MEDICAL TREATMENT TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85030 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR