BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY

    MDR report key: 1820371 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07337
    Event Type
    Injury
    Date Received
    August 30, 2010
    Report Date
    August 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 IN THIS CASE FAILED TESTING. SPC TEST PORT FOUND DIRTY. 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.

    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

    IT WAS REPORTED THAT A PT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT LEVEL T4. WHILE GAINING ACCESS TO THE VERTEBRAL BODY, AN ACCESS NEEDLE WAS INADVERTENTLY DIRECTED TOO FAR MEDIALLY, ENTERED THE SPINAL CANAL AND PUNCTURED THE SPINAL CORD. THE PHYSICIAN, UPON SEEING SPINAL FLUID, WITHDREW THE NEEDLE AND REDIRECTED IT. IT WAS NOTED THAT BONE CEMENT DID NOT EXTRAVASATE OUT OF THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. POST PROCEDURE, IN THE RECOVERY ROOM, THE PT NOTED MUSCLE WEAKNESS IN HER LEFT LEG WHILE SENSATION REMAINED INTACT. REPORTEDLY, THE PT REGAINED SOME MUSCLE STRENGTH; HOWEVER, FULL RECOVERY IS NOT EXPECTED. NO ADDITIONAL INFO WAS REPORTED. NOTE: THE ACCESS NEEDLE USED IN THIS PROCEDURE WAS NOT SOLD OR DISTRIBUTED BY MEDTRONIC SPINE LLC.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAEASY METER DISPLAYS AN ERROR 4 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN (B)(6) 2010 (DATE/TIME NOT SPECIFIED). THE PATIENT INDICATED SHE TESTS HER BLOOD GLUCOSE ONLY ONCE IN THE EVENING (BEFORE GOING TO BED) AND SHE DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN. ACCORDING TO THE CSR DOCUMENTATION, THE PATIENT CLAIMED THAT THE ALLEGED ISSUE WAS OCCURRING INTERMITTENTLY; HOWEVER, MORE RECENTLY THE ALLEGED ISSUE OCCURED EVERY EVENING. THE PATIENT INDICATED SHE DID NOT TEST HER BLOOD GLUCOSE WITH ANOTHER DEVICE AND CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE ALLEGED ISSUE BEGAN. AS A RESULT OF THE REPORTED METER ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF LIGHTHEADEDNESS, BLURRY VISION, SWEATING, AND SHAKING ON AN UNKNOWN DATE IN (B)(6) 2010 AT 2PM. ACCORDING TO THE CSR DOCUMENTATION, IN RESPONSE TO HER SYMPTOMS THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR DRINK; THE PATIENT INDICATED SHE WOULD FEEL BETTER APPROXIMATELY ONE HOUR LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE PATIENT FOLLOWED THE CORRECT BLOOD GLUCOSE TESTING PROCEDURE (PER OWNER'S BOOKLET). THE CSR ALSO NOTED THAT THE TEST STRIPS WERE WITHIN THE EXPIRATION DATE AND STORED PROPERLY, AS RECOMMENDED BY THE OWNER'S BOOKLET. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA EASY GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2966627

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening