BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4123965 · Received September 27, 2014

    Report

    Report Number
    2939301-2014-25673
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Report Date
    September 24, 2014
    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
    CA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A CONTINUOUS GLUCOSE MONITOR. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿329MG/DL¿ WITH THE SUBJECT METER AND ¿249MG/DL¿ ON A CONTINUOUS GLUCOSE MONITOR. AT THE TIME OF TROUBLESHOOTING A CONTROL SOLUTION TEST FELL OUTWITH LIFESCAN'S ACCEPTED CRITERIA AS PRINTED ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    603913 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3654627

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR