BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT TEST STRIPS BLUE

    MDR report key: 2180278 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06456
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. 510(K) # IS K043197.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011. THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS HAD PEELED AND CUT HER FINGER. ON (B)(6) 2011 THIS MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE BEGAN (B)(6) 2011. THE PATIENT FURTHER CLARIFIED THAT SHE HAS A SKIN CONDITION (NAME OF CONDITION NOT KNOWN) THAT CAUSES HER TO BE EASILY CUT. THE PATIENT FURTHER STATED THAT SHE TESTS TWICE A DAY AND MANAGES HER DIABETES WITH DIET AND EXERCISE. ON (B)(6) 2011, SHE WAS TESTING HER BLOOD GLUCOSE WHEN THE CUT OCCURRED. THE PATIENT REPORTED THAT SHE STARTED BLEEDING AND IMMEDIATELY DROVE HERSELF TO A CLINIC WHERE A NURSE APPLIED "STERI-STRIPS" AND A TOPICAL ANTIBIOTIC. THE PATIENT REPORTED THAT SHE FELT BETTER AFTER THE TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE PATIENT HAD DISCARDED ANY REMAINING STRIPS AND NONE WERE AVAILABLE FOR TROUBLESHOOTING OR EXAMINATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED STRIP ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT TEST STRIPS BLUE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3126957

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R