BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2183098 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06572
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 23, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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) K082590.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING THAT SHE WAS UNABLE TO OBTAIN A READING ON HER ONE TOUCH PING METER . A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT PRIOR TO TESTING ON THE MORNING OF (B)(6) 2011 AT 6:00 AM, SHE FELT SHAKY AND SWEATY. SHE THEN ATTEMPTED TO TEST HER BLOOD GLUCOSE FIVE MINUTES LATER AND THE METER WAS IN THE SETTINGS MODE AND SHE WAS UNABLE TO OBTAIN A READING. SHE THEN SELF-TREATED WITH FOOD /DRINK AT 6:15AM AND FELT BETTER SOON AFTER. SHE DID NOT ATTEMPT TO TEST ON ANOTHER DEVICE. THE PATIENT MENTIONED THAT THE NIGHT BEFORE AT 10:10PM SHE HAD TESTED AND OBTAINED A RESULT OF 85 MG/DL. CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO RESOLVE THE ISSUE AND SENT THE PATIENT A REPLACEMENT METER. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT DEVELOPED SYMPTOMS PRIOR TO TESTING. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3141671

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR