BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2251555 · Received September 16, 2011

    Report

    Report Number
    3008382007-2011-00406
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Report Date
    August 26, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS NOTED WITH THE TEST STRIPS, WHERE AN ERROR 4 MESSAGE WAS OBSERVED DURING PERFORMANCE TESTING WITH CONTROL SOLUTION. 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

    THE 510 (K) # IS K093745. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. TEST STRIPS HAVE BEEN RETURNED; HOWEVER, HAS NOT BEEN EVALUATED AT THIS TIME. LFS WILL EVALUATE THE TEST STRIPS AND SENT A SUPPLEMENTAL REPORT IF THE METER IS RETURNED, LFS WILL EVALUATE IT AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    THE PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE READINGS ON THEIR ONETOUCH VERIO METER. THE PATIENT COMPARED THEIR VERIO METER TO A ONE TOUCH ULTRA METER AND NOTICED ALLEGED HIGH READINGS ON THE VERIO METER. PATIENT OBTAINED AN 8.7 MMOL/L ON THE VERIO METER AND LESS THAN 30 MINUTES LATER TESTED ON A ONETOUCH ULTRA AND OBTAINED A 5.7 MMOL/L. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE DIFFERENCE BETWEEN BOTH METER WAS GREATER THAN 30% OR 30 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3074320

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR