BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING ENHANCED METER

    MDR report key: 3871067 · Received June 13, 2014

    Report

    Report Number
    2939301-2014-14375
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 10, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/30/2014), THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER READ INACCURATE COMPARED TO A LAB RESULT. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS WITH A "DIFFERENCE 27%" BETWEEN THE SUBJECT METER AND A LAB RESULT, NO EXACT VALUES WERE GIVEN . THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING, SINCE WE COULD NOT CONFIRM THAT THE CALCULATED DIFFERENCE EXCEEDED OUR CRITERIA AS NO VALUES WERE GIVEN. 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
    350633 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3520108

    Patients

    Seq Age Sex Outcome Treatment
    1