BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1871765 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09132
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 11, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS IN THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    REFERENCE: MDR 1220063-2010-00040. PER TELEPHONE COMMUNICATION WITH DRAEGER MEDICAL REGARDING THE SUBMITTAL OF ADDITIONAL MDRS FOR EACH SERIAL NUMBER LISTED ON THE INITIAL MDR SUBMITTED, DRAEGER IS SUBMITTING THIS REPORT. IT WAS REPORTED THAT THE DISPLAY OF THE INFINITY DELTA PRESENTS ALEATORY DISFUNCTIONS. IT WAS ALSO REPORTED THAT ONCE THE MONITOR IS RUNNING, THE "MENU" AND "STAND BY" WINDOW SUDDENLY APPEAR AND THERE IS NO WAY TO GET OUT OF IT BY PRESSING ANY OTHER KEY UNTIL IT DISAPPEARS BY ITSELF. THERE ARE NO ERRORS FOUND (IN THE ERROR LIST) THAT COULD BE ASSOCIATED TO THIS IRREGULARITY PRESENT BY THE EQUIPMENT. THERE WAS NO PT INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3016101

    Patients

    Seq Age Sex Outcome Treatment
    1