BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1918830 · Received December 9, 2010

    Report

    Report Number
    2939301-2010-10633
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6), 2010. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE REPORTER STATED THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION. ABOUT HALF AN HOUR AFTER THE ALLEGED ISSUE BEGUN, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF VOMITING AND DELIRIUM. BY 12PM THAT SAME DAY, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT "OVER 400 MG/DL" WITH THE ER/ HOSPITAL DEVICE. THE PATIENT WAS ADMINISTERED INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA TRIED TO WALK THE REPORTER THROUGH RESOLVING THE ALLEGED PRODUCT ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3010690

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R