BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1900592 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09936
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 16, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/14/2010. 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. THE METER WAS FOUND TO HAVE SPC PIN 2 LIFTED HIGH. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. 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

    THE 510 (K) # IS K001109. 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

    EXPLANTATION OF THE DEPUY HPS. STEM AND ASR CUP AND HEAD. HERE ARE ALL THE IMPLANT'S SERIAL NUMBERS AND LOT NUMBERS THAT WERE IMPLANTED ON (B)(6) 2006: ACETABULAR CUP, (B)(4), LOT# 1989378. HIP W/ STEM, (B)(4), LOT# Z4KHM1000. SLEEVE, (B)(4), LOT# 2142134. FEMORAL, (B)(4), LOT# 2163404.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(6) ON (B)(6) 2010 ALLEGING AN ERROR 4 MESSAGE ON HER ONE TOUCH ULTRA METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AND AT THE SAME TIME OF ATTEMPTING TO TEST SHE DEVELOPED SYMPTOMS OF FEELING SWEATY. THE PATIENT ATE MORE FOOD/DRINK AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TESTS TRIP WAS CORRECT. THE PATIENT RETESTED AND THE ALLEGED ISSUE WAS NOT RESOLVED VIA TROUBLESHOOTING. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 4 MESSAGE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3038004

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening