BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2537604 · Received April 17, 2012

    Report

    Report Number
    3008382007-2012-01551
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Report Date
    April 2, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT (LOT # 3230777) AS WELL AS TWO DIFFERENT VIALS (LOT #S 3273091 AND 3157522) HAVE BEEN RETURNED (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE ALLEGED ISSUE WAS CONFIRMED WHEN TESTING LOT# 3230777 WITH CONTROL SOLUTION DURING INVESTIGATION. ER4 WAS OBSERVED WITH LOT #3273091 WHEN TESTING WITH CONTROL SOLUTION. WITH LOT #3157522 AN ER4 WAS OBSERVED (WHILE TESTING WITH CONTROL SOLUTION) AND WAS ALSO FOUND TO HAVE EXTRA TEST STRIPS IN THE VIAL. 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

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN FROM (B)(4) ALLEGING AN ERROR 4 MESSAGE ISSUE WITH A ONE TOUCH VERIO PRO METER. THE PATIENT 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 CLAIMED THAT THE METER HAD AN ERROR 4 MESSAGE 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 PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR