BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2821650 · Received November 6, 2012

    Report

    Report Number
    3008382007-2012-06038
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 22, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ((B)(4))-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE ERROR 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

    SUPPLEMENTAL # 1 12/4/2012, THE TEST STRIPS WERE TESTED ON (B)(4) 2012 AND FAILED TESTING IT WAS NOTED THAT WHEN TESTING WITH A CONTROL SOLUTION ERROR 4 WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS HAVE BEEN RETURNED TO LIFESCAN (LFS) FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT'S PHARMACIST CONTACTED LIFESCAN FROM (B)(6) ALLEGING AN ERROR 4 MESSAGE ISSUE WITH THE ONE TOUCH VERIO PRO METER. THE PATIENT'S PHARMACIST DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S PHARMACIST CLAIMED THE METER HAD AN ERROR 4 MESSAGE ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S PHARMACIST 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 PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3278811

    Patients

    Seq Age Sex Outcome Treatment
    1