BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2792902 · Received October 16, 2012

    Report

    Report Number
    2939301-2012-12078
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 28, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A DEFECTIVE LCD. 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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH A 'BLUE SCREEN' DISPLAY ON THE PATIENT'S ONETOUCH PING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2012 THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN THROUGH PUMP THERAPY. THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. THE REPORTER DID NOT SPECIFY ANY SYMPTOMS THE PATIENT MAY HAVE DEVELOPED; HOWEVER, STATED THE PATIENT ADMINISTERED SELF 15-30 UNITS INSULIN BASED ON THE RESULTS OBTAINED WITH ANOTHER DEVICE. THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF '532, 479, 586, HIGH (OVER 600 MG/DL), 564, 522, 499, 556, 463, 425, 350, 407, 486, 533 AND 350 MG/DL' WITH THE OTHER DEVICE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OVER 500 MG/DL WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3346849

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R