BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3251331 · Received July 29, 2013

    Report

    Report Number
    3008382007-2013-21236
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/14/2013)-PRODUCT EVALUATION: THE ASSOCIATED TEST STRIPS WERE RETURNED ON (B)(4) 2013 AND ANALYSIS COMPLETED ON (B)(4) 2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ERROR 4 MESSAGE WAS OBSERVED WHEN THE TEST STRIPS WERE ANALYZED USING CONTROL SOLUTION. ECS-L TORN N CRITICAL WAS ALSO FOUND. 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 # 3 ¿ (12/26/2013). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/6/2013 AND 12/17/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS VIAL WAS FOUND TO BE EXPOSED. 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 # 2 ¿ ((B)(4) 2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO BE UNABLE TO REPRODUCE AN ERROR 4 MESSAGE. 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

    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) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH VERIO METER DISPLAYED AN ¿ERROR 4¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF CHANGES WERE MADE TO HER USUAL MANAGEMENT ROUTINE. ABOUT 20 MINUTES PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SWEATING, TREMBLING AND HEART BEATING FASTER. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THE CCA EDUCATED THE PATIENT ABOUT TESTING WITH EXPIRED TEST STRIPS. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT¿S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ¿ERROR 4¿ MESSAGE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352781 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3309025

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR