BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4489254 · Received February 6, 2015

    Report

    Report Number
    2939301-2015-04533
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Report Date
    January 20, 2015
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (03/10/2015).THE PATIENT¿S METER HAS BEEN RETURNED ON 2/17/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 2/27/2015 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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

    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) 2015, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER (ONETOUCH PING) READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE ON THREE OCCASIONS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF "299, 336 AND 350MG/DL" RESPECTIVELY WITH THE SUBJECT METER AND "111, 167 AND 248MG/DL" RESPECTIVELY ON ANOTHER DEVICE. ALL THREE COMPARISONS WERE PERFORMED SEPARATELY, BUT EACH METER/METER COMPARISON WAS PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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
    88008 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3524271

    Patients

    Seq Age Sex Outcome Treatment
    1