BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2820744 · Received November 6, 2012

    Report

    Report Number
    3008382007-2012-06018
    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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON NOVEMBER 1, 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE OBSERVED AND FOUND TO HAVE FAILED. THE TEST STRIPS WERE CONFIRMED TO HAVE BEEN MISCUT . 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) 2012, THE LAY-USER/PATIENT'S PHARMACIST CONTACTED LIFESCAN FROM (B)(6), ALLEGING A STRIP CUT ISSUE WITH THE ONE TOUCH VERIO TEST STRIPS. IT WAS NOTED THAT THE TEST STRIPS WERE CUT ON BOTH SIDES. THE APPLY WINDOW PART OF THE TEST STRIPS LOOKED LIKE THE PART THAT IS INSERTED INTO THE 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 PRODUCT WAS SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S PHARMACIST CLAIMED A STRIP CUT ISSUE WITH THE ONE TOUCH VERIO TEST STRIPS. 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 TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3276713

    Patients

    Seq Age Sex Outcome Treatment
    1