BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 1994079 · Received February 16, 2011

    Report

    Report Number
    2939301-2011-01415
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/21/11)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER, RETURNED TEST STRIPS, AND RETAIN TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. 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 ULTRAMINI METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS THREE TIMES A DAY AND MANAGES HER DIABETES WITH 1000MG OF METFORMIN TWICE A DAY AND A SECOND (TYPE UNKNOWN) DIABETES ORAL MEDICATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 8:30 AM. THE PATIENT CLARIFIED SHE OBTAINED BLOOD GLUCOSE RESULTS OF "212 AND 278MG/DL" WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES OF EACH OTHER. THE PATIENT CONFIRMED SHE DID NOT TAKE ANY ACTION IN RESPONSE TO THE ALLEGED ISSUE. TWO HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CONFIRMED SHE DEVELOPED A SYMPTOM OF SHAKING; A SYMPTOM THE PATIENT ASSOCIATED WITH LOW BLOOD GLUCOSE. AT THE ONSET OF HER REPORTED SYMPTOM, THE PATIENT CORRECTED AND CLARIFIED SHE ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND FELT BETTER APPROXIMATELY 30 MINUTES LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. REPLACEMENT PRODUCTS WERE 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 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2966622

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening