BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2771210 · Received October 3, 2012

    Report

    Report Number
    3008382007-2012-04749
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 27, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (SUBMISSION 11/27/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE TEST STRIPS WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON 11/01/2012. THE RETURNED TEST STRIPS PASSED TESTING. THE ALLEGED COMPLAINT WAS NOT CONFIRMED. HOWEVER, AS SECONDARY ISSUE WAS DISCOVERED DURING INVESTIGATIONS. THE CONTROL SOLUTION TEST RESULT WAS ABOVE THE EXPECTED RANGE WHEN TESTING WITH THE RETURNED TEST STRIPS.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO PRO WAS GIVING INACCURATELY LOW READINGS. THE PATIENT REPORTED HE OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 80 MG/DL TO 120 MG/DL, WHICH HE ALLEGED WERE INACCURATELY LOW COMPARED TO HIS EXPECTED VALUES. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    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