BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEV

    MDR report key: 1883707 · Received October 27, 2010

    Report

    Report Number
    2939301-2010-09523
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    October 12, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S LANCING DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE LANCING DEVICE INVOLVED IN THIS CASE FAILED TESTING. THE CASING THREADS WERE STRIPPED. THEREFORE, THE COMPLAINT IS CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER SALES REPRESENTATIVE OF ONE CLEARLINK EXTENSION SET WITH 0.22 MICRON FILTER, IN WHICH SOMETHING VISIBLY DARK WAS OBSERVED IN THE FILTER AREA AFTER THE PATIENT WAS CONNECTED TO THE LINE. THE PARTICULATE MATTER OBSERVED WAS TINY DARK PARTICLES AND THEY DID NOT MAKE IT TO THE PATIENT. THE IV WAS STARTED AND IT WAS OBSERVED ALMOST RIGHT AWAY. THE MEDICATION THAT WAS USED IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE THREADS ON HIS ONETOUCH ULTRASOFT LANCING DEVICE ARE STRIPPED/ DAMAGED. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT DOES NOT KNOW WHEN THE ALLEGED ISSUE BEGAN. IN ADDITION, TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED HE ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, ON AN UNKNOWN DATE/TIME THE PATIENT CLAIMED HE CONSUMED MORE FOOD/DRINK IN RESPONSE TO THE REPORTED LANCING DEVICE ISSUE. FIVE DAYS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF BLURRY VISION AND TIREDNESS. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION OR TREATMENT FOLLOWING THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THERE WAS NO MISUSE OF THE LFS PRODUCT AND THE PATIENT WAS NOT USING THE SUBJECT LANCING DEVICE FOR THE FIRST TIME. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEV GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening