BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2232805 · Received September 2, 2011

    Report

    Report Number
    3008382007-2011-00309
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED AND FOUND TO HAVE FAILED FOR CONTROL SOLUTION HIGH. UNRELATED TO THE ISSUE, THERE WAS AN ERROR 4 ISSUE. 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

    510 (K) # IS K093745 . 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). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2012 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 ONE TOUCH VERIO PRO METER. THE PATIENT OBTAINED THE FOLLOWING READINGS:19,2, 7.4, 10.3 AND 5.8 MMOL/L WITHIN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE READINGS ARE GREATER THAN 12 MG/DL (0.67 MMOL/L) OR 15%.

    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 3159868

    Patients

    Seq Age Sex Outcome Treatment
    1