BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1843180 · Received September 24, 2010

    Report

    Report Number
    2939301-2010-08382
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Report Date
    September 16, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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'S DISPLAY WAS FOUND TO BE CRACKED/BROKEN. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    A 510 (K) # IS K082590.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE PUMP WITH FAILURE CODE 808:02. IT WAS NOT SPECIFIED WHEN REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. DURING REVIEW OF THE EVENT HISTORY IT WAS DETERMINED THAT THE REPORTED CONDITION OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A PURPLE SPOT ON THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3029126

    Patients

    Seq Age Sex Outcome Treatment
    1