BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2770474 · Received October 3, 2012

    Report

    Report Number
    3008382007-2012-04715
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 25, 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

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS OBSERVED WHERE ERROR 4 WAS PRODUCED DURING A CONTROL SOLUTION TEST. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 (SUBMISSION 11/27/2012)-DEVICE EVALUATION: LIFESCAN (LFS) 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. AN 'ERROR 4' OCCURRED WHEN CONDUCTING A CONTROL SOLUTION TEST RESULT WITH THE RETURNED TEST STRIPS. LFS ALSO RECEIVED THE METER INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2012. THE RETURNED METER PASSED TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIOPRO METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "11.4 MMOL/L" WITH THE SUBJECT METER AND "5.8 MMOL/L" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    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 3156292

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR