BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3930780 · Received July 12, 2014

    Report

    Report Number
    2939301-2014-17222
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Report Date
    July 9, 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

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCTS FOR EVALUATION. IF THE PRODUCTS ARE RETURNED, LFS WILL EVALUATE THEM AND INFORM THE FDA OF PRODUCTS THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/02/2015). THE PATIENT¿S METER HAS BEEN RETURNED ON 12/16/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/12/2015 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE CONTAMINATED SPC PINS. IN ADDITION, A TERTIARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO BE MISSING A BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. FOUND PCB AND SPC PINS CONTAMINATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING UNUSUAL ISSUE, THAT THE METER POWERS ON WITHOUT PROMPT. 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
    408569 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3605144

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR