BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2402871 · Received January 7, 2012

    Report

    Report Number
    3008382007-2012-00029
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Report Date
    December 12, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. LOT # IS 3202762, SERIAL # (B)(4) REFERS TO THE ONE TOUCH VERIO PRO METER, 510 (K) # IS K093745.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN FROM THE (B)(6) ALLEGING A TEST STRIP ISSUE WITH SOME ONE TOUCH VERIO TEST STRIPS. THE PATIENT ALLEGED THAT AN UNSPECIFIED ERROR MESSAGE HAD OCCURRED UPON THE INSERTION OF 15 TEST STRIPS INTO A ONE TOUCH VERIOPRO METER. HOWEVER, THE ALLEGED ISSUE WAS REPORTEDLY RESOLVED WHEN THE PATIENT TRIED A NEW PACKAGE OF TEST STRIPS. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE METER HAD A TEST STRIP ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1