BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3082568 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09391
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 ((B)(4) 2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE ALLEGED COMPLAINT WAS NOT REPRODUCIBLE. THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183949 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3389702

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR