BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PENLET PLUS

    MDR report key: 2141781 · Received June 27, 2011

    Report

    Report Number
    2939301-2011-05274
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    June 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE COCKING CONTROL ON THE PATIENT'S ONETOUCH ULTRASOFT LANCING DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT OR THE REPORTER FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY 2 MONTHS AGO PRIOR TO CONTACTING LFS. IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES, BUT THE REPORTER STATED THE PATIENT RESPONDED TO EATING MORE FOOD/DRINK AT THE TIME THE ALLEGED ISSUE BEGAN. THE REPORTER CLAIMED THE PATIENT WAS FEELING SHAKY PRIOR TO THE START OF THE ALLEGED ISSUE. A MONTH PRIOR TO CONTACTING LFS, THE REPORTER INDICATED THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR ASSISTANCE AND WAS ADMINISTERED AN UNKNOWN TYPE/DOSE OF INSULIN. IT IS NOT KNOWN WHETHER THE PATIENT WAS TESTED ON ANOTHER DEVICE AT THE TIME OF THE ER. AROUND THE SAME TIME THE ALLEGED ISSUE BEGAN, THE REPORTER ALSO INDICATED THE PATIENT HAD OBTAINED A READING OF "695 MG/DL" AT THE LAB; HOWEVER IT IS NOT KNOWN WHAT KIND TREATMENT, IF ANY, THE PATIENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSED OF THE LANCING DEVICE SINCE THE REPORTER STATED THE PATIENT HAD BEEN USING THE LANCING DEVICE FOR 1 1/2 YEARS. A REPLACEMENT PRODUCT WAS 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 PENLET PLUS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R