BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2038013 · Received April 4, 2011

    Report

    Report Number
    2939301-2011-02749
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A BROKEN DISPLAY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K080639.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S GRANDMOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER HAD BLACK MARKS ON THE DISPLAY. ON (B)(6) 2011, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT'S GRANDMOTHER INFORMED THE MSS THAT THE PATIENT'S TESTING FREQUENCY IS 3-4 TIMES DAILY AND MANAGES HIS DIABETES WITH AN INSULIN PUMP (NOVOLOG). THE PATIENT'S GRANDMOTHER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6:30PM. AS A RESULT OF THE ALLEGED ISSUE, THE GRANDMOTHER CONFIRMED THE PATIENT DID NOT TAKE ANY ACTION REGARDING THE PATIENT'S DIABETES MANAGEMENT ROUTINE. AT AN UNKNOWN TIME LATER, THE GRANDMOTHER CONFIRMED THE PATIENT BECAME UNCONSCIOUS AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO HIS SYMPTOM, THE GRANDMOTHER CONFIRMED EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED FOR ASSISTANCE. WHEN THE EMS ARRIVED, THE GRANDMOTHER STATED THE PATIENT WAS TESTED BY THE EMS METER WITH A RESULT OF "27 MG/DL" AND WAS THEN IMMEDIATELY GIVEN OXYGEN AND WAS ADMINISTERED IV FLUIDS WITH SUGAR. ACCORDING TO THE GRANDMOTHER, ½ AN HOUR AFTER THE PATIENT T RECEIVED THE TREATMENT BY EMS, THE PATIENT FELT BETTER AND WAS TESTED AGAIN BY THE EMS METER WITH A READING OF "150 MG/DL". THE GRANDMOTHER STATED THEY DID ATTEMPT TO USE THE SUBJECT METER AT THE TIME OF THE ALLEGED ISSUE AND A READING WAS OBTAINED; HOWEVER THEY COULD ONLY SEE HALF OF THE SCREEN. THE GRANDMOTHER CONFIRMED THE PATIENT HAD NO OTHER BLOOD GLUCOSE DEVICE USED AT THE TIME THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE AND THERE WAS NO MISUSED OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S GRANDMOTHER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AND REPORTEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER (HCP) AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R