BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2802694 · Received October 24, 2012

    Report

    Report Number
    3008382007-2012-05495
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    October 5, 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
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT'S PHARMACIST CONTACTED LIFESCAN FROM (B)(6) ALLEGING A STRIP ISSUE WITH THE ONE TOUCH VERIO TEST STRIPS. IT WAS NOTED THAT THE PHARMACIST WAS NOT ABLE TO DETERMINE THE ISSUE WITH THE TEST STRIPS. THE PATIENT'S PHARMACIST DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S PHARMACIST CLAIMED A STRIP 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 3261099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR