BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4171876 · Received October 15, 2014

    Report

    Report Number
    2939301-2014-27519
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/26/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 11/13/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/12/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    CORRECTION TO INCIDENT DESCRIPTION: ON (B)(6) /2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS OF "LOW GLUCOSE AND 178 MG/DL" PERFORMED ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED THE REPORTED RESULTS DO NOT MEET LFS' PRECISION CRITERIA AND THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, 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
    654090 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3644188

    Patients

    Seq Age Sex Outcome Treatment
    1