BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2932037 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01679
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/13/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2013 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. 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

    THE PATIENT'S PRODUCTS HAVE BEEN RETURNED TO LIFESCAN FOR EVALUATION; HOWEVER, THE EVALUATION PROCESS HAS NOT YET BEEN COMPLETED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER MARKED THE BLOOD TEST AS A CONTROL SOLUTION TEST. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37374 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR