BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2233640 · Received September 2, 2011

    Report

    Report Number
    3008382007-2011-00331
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 11, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4) 2011 THE METER WAS TESTED AND NO FAULTS WERE FOUND. ON (B)(4), 2011 THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. A SECONDARY ISSUE WAS NOTED: DURING TESTING WITH CONTROL SOLUTION AN APPLY SAMPLE MESSAGE WAS OBSERVED WITH NO ASSIGNABLE CAUSE. 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 METER HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN (B)(4) ON BEHALF OF HIS SON (THE PATIENT) ALLEGING THAT A ONE TOUCH VERIO PRO METER HAD AN ERROR 4 ISSUE. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE METER HAD AN ERROR 4 ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER 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 PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR